search
Back to results

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma (FIRST)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide and low-dose dexamethasone
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Melphalan, Prednisone and Thalidomide
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring newly diagnosed multiple myeloma, Lenalidomide, Revlimid, phase III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must understand and voluntarily sign informed consent form
  2. Age ≥ 18 years at the time of signing consent

  3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:

    • MM diagnostic criteria (all 3 required):
    • Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
    • Monoclonal protein present in the serum and/or urine
    • Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis

    AND have measurable disease by protein electrophoresis analyses as defined by the following:

    • IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
    • IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
    • IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
    • IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
    • Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours

    AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:

    • The patient declines to undergo stem cell transplantation or
    • Stem cell transplantation is not available to the patient due to cost or other reasons
  4. ECOG performance status of 0, 1, or 2
  5. Able to adhere to the study visit schedule and other protocol requirements

  6. Females of child-bearing potential (FCBP)^2:

    1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
    2. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.

  7. Male Patients:

    1. Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
    2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
    3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.

  8. All patients must:

    1. Have an understanding that the study drug could have a potential teratogenic risk.
    2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
    3. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.

Exclusion Criteria:

  1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
  2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
  3. Pregnant or lactating females.

  4. Any of the following laboratory abnormalities:

    • Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)
    • Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
    • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
  5. Renal failure requiring hemodialysis or peritoneal dialysis.

  6. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
  7. Patients who are unable or unwilling to undergo antithrombotic therapy.
  8. Peripheral neuropathy of > grade 2 severity.

  9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.

    • 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
    • 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Sites / Locations

  • University of AL Birmingham
  • Cedar Sinai Medical Center Dept of Medicine
  • University of California, San Francisco- California
  • Stanford University Stanford
  • Gainesville Heme Oncology Associates
  • Baptist Cancer Institute
  • Integrated Community Oncology Network
  • Gulf Coast Oncology
  • Palm Beach Cancer Institute, LLC
  • Southern Illinois Hematology Oncology
  • Orchard Healthcare Research, Inc.
  • John H Stroger Hospital of Cook County
  • Rush University Medical Center
  • Ingalls Cancer Institute
  • Cancer Center of Kansas
  • Maine Center for Cancer Medicine Blood Disorders
  • Center for Cancer and Blood Disorders
  • Mayo Clinic Cancer Center
  • Billings Clinic
  • Arena Oncology Associates, PC
  • Dakota Cancer Institute
  • Gabrail Cancer Center Research
  • University Hospitals of Cleveland
  • Cleveland Clinic
  • Kaiser Permanente Northwest Oncology Hematology
  • St. Luke's Hospital and Health Network
  • University of Pennsylvania
  • The Cancer Center
  • University of Tennessee Cancer Institute
  • University of Texas Medical Branch
  • Swedish Cancer Institute
  • Fred Hutchinson Cancer Center
  • Royal Adelaide Hospital
  • Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
  • Western Hospital
  • Frankston Hospital
  • Flinders Medical Centre
  • Geelong Hospital
  • Gosford Hospital
  • Royal Brisbane and Women's Hospital
  • Cabrini Hospital
  • The Royal Melbourne Hospital
  • Royal Perth Hospital
  • Gold Coast Hospital
  • Royal North Shore Hospital
  • Westmead Hospital
  • Border Medical Oncology
  • Wollongong Hospital
  • Princess Alexandra Hospital
  • Hospital Leoben
  • Hospital of Barmherzige Schwestern Linz
  • Hospital of Elisabethinen Linz
  • General Hospital Linz
  • MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
  • Hospital St. Polten
  • Hospital of the Barmherzigen Bruder Vienna
  • MM-015.Wihelminenspital
  • MM-015. Medizinische Universität Wien
  • Hospital Wels
  • Hospital Wiener Neustadt
  • ZNA Stuivenberg Centrumziekenhuis
  • Les Cliniques du Sud Luxembourg
  • AZ St-Jan Brugge Oostende AV
  • Hopital Erasme
  • AZ-VUB
  • Jules Bordet Institut
  • Cliniques Universitaires St-Luc
  • Universitair Ziekenhuis Antwerpen
  • UZ Gent
  • Virga Jesse Ziekenhuis
  • Universitair Ziekenhuis Leuven, Campus Gasthuisberg
  • H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
  • Cliniques Universitaires UCL de Mont-Godine
  • University of Calgary
  • Cross Cancer Institute
  • British Columbia Cancer Agency
  • Royal Columbian Hospital
  • BC Cancer Agency - Fraser Valley Centre
  • Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
  • Vancouver Island Cancer Center
  • Saint John Regional Hospital
  • Queen Elizabeth II Health Sciences Center
  • Juravinski Cancer Centre
  • London Health Science Centre
  • Ottawa Hospital
  • Odette Cancer Centre
  • Princess Margaret Hospital
  • Hospital Charles LeMoyne
  • Hopital de la Cite-de-la-Sante
  • Hotel-Dieu de Levis
  • Hopital du Sacre-Coeur de Montreal
  • Hospital Maisonneuve - Rosemont
  • CHUM- Hopital Notre-Dame
  • McGill University
  • Sir Mortimer B. Davis - Jewish Genl
  • CHUQ - Hotel-Dieu de QuebecHematology - Oncology
  • Chaoyang Hospital
  • Peking University People's Hospital
  • West China Hospital of Sichuan University
  • Ruijin Hospital Shanghai Jiaotong University
  • Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
  • Clinique Claude BernardOncologie
  • CHU Sud
  • CHRU Hopital du bocage
  • CH Argenteuil Victor Dupouy
  • Centre Hospitalier de la cote basque
  • Centre Hospitalier
  • Hopital Avicenne
  • Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
  • Polyclinique Bordeaux Nord Aquitaine
  • Hopital de Fleyriat
  • Hopital Augustin Morvan
  • Centre Francois Baclesse
  • CHU
  • CH
  • CH Rene Dubois
  • Centre Hospitalier William Morey
  • Hopital dinstruction des armees Percy
  • Hopital Antoine Beclere
  • Chu Estaing
  • CH Louis Pasteur
  • Hopital Henri Mondor
  • CHRU Hopital du bocage
  • Centre Hospitalier General
  • CHRU
  • Institut Prive de Cancerologie
  • Centre Hospitalier Departemental
  • CH
  • Hopital J MonodRhumato Nord
  • Kremlin Bicetre
  • Centre Hospitalier
  • Centre Jean Bernard
  • CHRU-Hopital Claude Huriez
  • GH de Institut Catholique St Vincent
  • CH - Hôpital Dupuytren
  • CHU Hopital Edouard Herriot
  • Centre Leon Berard
  • Centre Hospitalier de Valence
  • Institut Paoli-Calmettes
  • Hopital de Mercy
  • Clinique Pont de chaume Oncologie et Radiotherapie
  • CHU Montpellier - Hôpital Lapeyronie
  • Hopital Emile Muller
  • CHRU - Hotel Dieu
  • Centre Antoine Lacassagne Oncologie medicale et Hematologie
  • Hopital de lArchet 1
  • CH La Source
  • Hopital Cochin
  • Hopital Saint Louis
  • Hopital Necker
  • CHU Hôpital St-Antoine
  • CHRU - Hopital du Haut Leveque
  • CU CHU Clemenceau
  • Hopital R. Debre
  • CHU Reims - Hôpital Maison Blanche
  • CHRU Hopital sud Medecine Interne
  • CHRU Hôpital de Pontchaillou
  • CHG Rodez
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • Institut de Cancerologie de Loire
  • Centre Hospitalier Yves Le Foll
  • CHRU Hôpital de Hautepierre
  • CHRU Hopital Purpan
  • CHRU Hopital Bretonneau
  • CHRU Hopital Trousseau
  • CHRU Hôpitaux de Brabois
  • CH P. Chubert
  • Institut Gustave Roussy
  • Medizinische Kinik und Poliklinik I
  • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
  • Universitatsklinikum Essen-
  • Staedtische Kliniken Frankfurt am Main Hochst
  • Universitatsklinikum Giessen
  • Ernst-Moritz-Arndt-Universität Greifswald
  • Askepios Klinik St. Georg
  • Universitatsklinikum Jena
  • Medizinische Klinik und Poliklinik II
  • Universitatsklinikum schleswig-Holstein
  • Poliklinik A
  • Klinikum der Johann-Wolfgang-Goethe-Universtat
  • Medizinische Klinik III Klinikum der Universität München-Großhadern
  • Medizinische Fakultat der Universitat Rostock
  • Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
  • Medizinische Klinik - Abteilung II
  • Klinik fur Innere Medizin III
  • Alexandra Hospital, University of Athens
  • Attiko Hospital of Athens
  • Evangelismos Hospital of Athens
  • University of Athens
  • Metaxa Hospital Peiraias
  • Theagenio Anticancer Hospital of Thessaloniki
  • Adelaide and Meath Hospital
  • Mater Misercordiae Hospital
  • University Hospital Galway
  • Policlinico S. Orsola
  • Oncologia Medica, Università della Magna Grecia
  • Clinica Ematologica, A.O.U. San Martino di Genova
  • Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
  • Unità Operativa di Oncoematologia, Ospedale di Matera
  • U.O. di Ematologia e Trapianto di Midollo Osseo
  • Istituto Europeo di Oncologia - IEO
  • Presidio Ospedaliero A. Perrino
  • Policlinico di Modena
  • Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
  • Casa di Cura La Maddalena, Divisione di Ematologia
  • Policlinico San Matteo Universita Di Pavia
  • Ospedale Civile
  • A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
  • Arcispedale Santa Maria Nuova
  • Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
  • Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
  • Ospedale Molinette
  • Hallym University Sacred Heart Hospital
  • Inje University Busan Paik Hospital
  • Daegu Catholic University Medical Center 3056-6
  • Chungnam National University Hospital
  • National Cancer Center
  • Hwasun Chonnam National University Hospital
  • Gachon University Gil Hospital
  • Chonbuk National University Hospital 42
  • Seoul National University Bundang Hospital
  • Severance Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • The Catholic University of Korea Seoul - Saint Mary's Hospital
  • Asan Medical Center
  • Ewha Womans University Mokdong Hospital
  • Auckland City Hospital
  • Christchurch Hospital
  • Wellington Hospital
  • Hospital de Sao Marcos
  • Hospitais da Universidade de Coimbra
  • Instituto Portugues de Oncologia de Lisboa
  • Hospital de Santa Maria
  • Instituto Português de Oncologia Porto
  • Hospital de Santo Antonio- Porto
  • Hospital Universitari Germans Trias i Pujol
  • Hospital de la Santa Creu i Sant Pau
  • Instituto Catalan de Oncologia-Hospital Duran
  • Hospital Reina Sofia
  • Hospital Univ. Josep Trueta
  • Hospital Clinico San Carlos
  • Hospital 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital General Universitario Morales Messeguer
  • Hospital Clinico Virgen de la Victoria
  • Hospital Son Llatzer
  • Clinica Universitaria de Navarra,
  • Hospital Sant Pau
  • Hospital de Donosti
  • Hospital Universtario Marques de Valdecilla
  • Hospital Clinico Santiago de Compostela
  • Hosptial La Fe
  • Hospital Clinico Universitario de Valencia
  • Hospital Clinico Universitario Lozano Blesa
  • Hospital Miguel Servet
  • Linkoping University Hospital
  • Karolinska University HospitalSolna
  • St. Görans Hospital
  • Karolinska University Hospital Huddinge
  • Abteilung Onkologie Haematologie des Kantonsspitals Aarau
  • UniversitatsSpital Basel
  • Inselsspital Bern
  • Kantonsspital Graubunden
  • Centre Hospitalier Universitaire Vaudois CHUV
  • Kantonsspital Munsterlingen
  • Kantonsspital Winterthur
  • China Medical University Hospital
  • Veteran General Hospital - Taipei
  • National Taiwan University Hospital
  • Gwynedd Hospital
  • Royal United Hospital
  • Belfast City Hospital Haematology Department
  • Birminghman QE
  • Royal Bournemouth Hosp
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital
  • University Hospital of Wales - Cardiff
  • The Beatson West of Scotland Centre
  • Dept of Haematology St Bartholomews Hospital
  • Guy's and St Thomas' Hospital - London
  • Royal Free Hospital
  • Churchhill Hospital
  • Derriford Hospital
  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
  • Pinderfields General Hospital
  • New Cross Hospital- Wolverhampton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Lenalidomide / Dexamethasone until disease progression

Lenalidomide / Dexamethasone for 18 cycles

Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles

Arm Description

Lenalidomide plus low-dose dexamethasone given until disease progression

Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles

Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles

Outcomes

Primary Outcome Measures

Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).

Secondary Outcome Measures

Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.
Percentage of Participants With an Objective Response Based on IRAC Review
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
Time to First Response Based on the Review by the IRAC
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.
Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.
Kaplan Meier Estimates of Time to Treatment Failure (TTF)
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.
Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.
Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Change From Baseline in the EORTC QLQ-C30 Pain Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.
Change From Baseline in the EORTC QLQ-C30 Constipation Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.
Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.
Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.
Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state.
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.
Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.
Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base
Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.

Full Information

First Posted
June 2, 2008
Last Updated
November 7, 2019
Sponsor
Celgene
search

1. Study Identification

Unique Protocol Identification Number
NCT00689936
Brief Title
Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
Acronym
FIRST
Official Title
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 21, 2008 (Actual)
Primary Completion Date
July 14, 2016 (Actual)
Study Completion Date
July 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Detailed Description
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease [PD] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
newly diagnosed multiple myeloma, Lenalidomide, Revlimid, phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide / Dexamethasone until disease progression
Arm Type
Experimental
Arm Description
Lenalidomide plus low-dose dexamethasone given until disease progression
Arm Title
Lenalidomide / Dexamethasone for 18 cycles
Arm Type
Experimental
Arm Description
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Arm Title
Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles
Arm Type
Active Comparator
Arm Description
Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
Intervention Type
Drug
Intervention Name(s)
Lenalidomide and low-dose dexamethasone
Other Intervention Name(s)
Revlimid
Intervention Description
Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression
Intervention Type
Drug
Intervention Name(s)
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Other Intervention Name(s)
Revlimid
Intervention Description
lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles
Intervention Type
Drug
Intervention Name(s)
Melphalan, Prednisone and Thalidomide
Other Intervention Name(s)
Prednisone, Thalomid
Intervention Description
Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
Description
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
Time Frame
From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
Title
Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
Description
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
Time Frame
From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Secondary Outcome Measure Information:
Title
Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
Description
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.
Time Frame
From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
Title
Percentage of Participants With an Objective Response Based on IRAC Review
Description
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Description
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Description
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
Title
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Description
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
Time Frame
Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
Title
Time to First Response Based on the Review by the IRAC
Description
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
Description
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Title
Kaplan Meier Estimates of Time to Treatment Failure (TTF)
Description
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
Time Frame
From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
Title
Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
Description
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
Time Frame
From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
Title
Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
Description
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.
Time Frame
From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
Title
Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
Description
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.
Time Frame
From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
Title
Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
Description
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
Description
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
Description
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
Description
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
Description
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame
Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
Title
Change From Baseline in the EORTC QLQ-C30 Pain Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Constipation Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
Description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Description
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
Description
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Description
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
Description
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
Description
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state.
Time Frame
Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Title
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
Description
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Time Frame
Day 1 (randomization) up to last visit completed 25 July 2016
Title
Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
Description
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.
Time Frame
From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
Description
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.
Time Frame
Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
Description
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Time Frame
Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
Description
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Time Frame
Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
Description
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Time Frame
Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Title
Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base
Description
Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.
Time Frame
From randomization to 24 May 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must understand and voluntarily sign informed consent form Age ≥ 18 years at the time of signing consent Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required): Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma Monoclonal protein present in the serum and/or urine Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following: IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because: The patient declines to undergo stem cell transplantation or Stem cell transplantation is not available to the patient due to cost or other reasons ECOG performance status of 0, 1, or 2 Able to adhere to the study visit schedule and other protocol requirements Females of child-bearing potential (FCBP)^2: Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. Male Patients: Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. All patients must: Have an understanding that the study drug could have a potential teratogenic risk. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure. Exclusion Criteria: Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]). Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Pregnant or lactating females. Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L) Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L) Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) Renal failure requiring hemodialysis or peritoneal dialysis. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) Patients who are unable or unwilling to undergo antithrombotic therapy. Peripheral neuropathy of > grade 2 severity. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related. 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jacques, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of AL Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cedar Sinai Medical Center Dept of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, San Francisco- California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Gainesville Heme Oncology Associates
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Integrated Community Oncology Network
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Gulf Coast Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Palm Beach Cancer Institute, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Southern Illinois Hematology Oncology
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Orchard Healthcare Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ingalls Cancer Institute
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426-3558
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Maine Center for Cancer Medicine Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Arena Oncology Associates, PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Dakota Cancer Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kaiser Permanente Northwest Oncology Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
St. Luke's Hospital and Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0561
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
City
E. Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Gold Coast Hospital
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Wentworthville
ZIP/Postal Code
2145
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
Facility Name
Wollongong Hospital
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Hospital Leoben
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
Hospital of Barmherzige Schwestern Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Hospital of Elisabethinen Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
General Hospital Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hospital St. Polten
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Hospital of the Barmherzigen Bruder Vienna
City
Vienna
ZIP/Postal Code
1020
Country
Austria
Facility Name
MM-015.Wihelminenspital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
MM-015. Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Hospital Wels
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Hospital Wiener Neustadt
City
Wiener Neustadt
Country
Austria
Facility Name
ZNA Stuivenberg Centrumziekenhuis
City
Antwerpen
ZIP/Postal Code
2069
Country
Belgium
Facility Name
Les Cliniques du Sud Luxembourg
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
AZ-VUB
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Jules Bordet Institut
City
Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Virga Jesse Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godine
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3M 1X4
Country
Canada
Facility Name
BC Cancer Agency - Fraser Valley Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver Island Cancer Center
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3L6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hospital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hopital de la Cite-de-la-Sante
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Hotel-Dieu de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G5V 3Z1
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
G4H 1C5
Country
Canada
Facility Name
Hospital Maisonneuve - Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM- Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Sir Mortimer B. Davis - Jewish Genl
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHUQ - Hotel-Dieu de QuebecHematology - Oncology
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Chaoyang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Tianjin
ZIP/Postal Code
300041
Country
China
Facility Name
Clinique Claude BernardOncologie
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
CHU Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHRU Hopital du bocage
City
Angers cedex 01
ZIP/Postal Code
49033
Country
France
Facility Name
CH Argenteuil Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Centre Hospitalier de la cote basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Centre Hospitalier
City
Blois cedex
ZIP/Postal Code
41016
Country
France
Facility Name
Hopital Avicenne
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Hopital de Fleyriat
City
Bourg en Bresse cedex
ZIP/Postal Code
01012
Country
France
Facility Name
Hopital Augustin Morvan
City
Brest cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Francois Baclesse
City
Caen cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CH
City
Cannes Cedex
ZIP/Postal Code
06401
Country
France
Facility Name
CH Rene Dubois
City
Cergy-Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon/Saone Cedex
ZIP/Postal Code
71321
Country
France
Facility Name
Hopital dinstruction des armees Percy
City
Clamart Cedex
ZIP/Postal Code
92141
Country
France
Facility Name
Hopital Antoine Beclere
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Chu Estaing
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CH Louis Pasteur
City
Colmar cedex
ZIP/Postal Code
68024
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHRU Hopital du bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Hospitalier General
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
CHRU
City
Grenoble cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Institut Prive de Cancerologie
City
Grenoble
ZIP/Postal Code
38034
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche -Sur-Yon cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
CH
City
Le Chesnay Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
Hopital J MonodRhumato Nord
City
Le Havre
ZIP/Postal Code
76000
Country
France
Facility Name
Kremlin Bicetre
City
Le Kremlin bicetre CDX
ZIP/Postal Code
942975
Country
France
Facility Name
Centre Hospitalier
City
Le Mans cedex
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHRU-Hopital Claude Huriez
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
GH de Institut Catholique St Vincent
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CH - Hôpital Dupuytren
City
Limoges Cedex 1
ZIP/Postal Code
87042
Country
France
Facility Name
CHU Hopital Edouard Herriot
City
Lyon cedex
ZIP/Postal Code
69437
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Hospitalier de Valence
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13009
Country
France
Facility Name
Hopital de Mercy
City
METZ cedex 3
ZIP/Postal Code
57085
Country
France
Facility Name
Clinique Pont de chaume Oncologie et Radiotherapie
City
Montauban cedex
ZIP/Postal Code
82017
Country
France
Facility Name
CHU Montpellier - Hôpital Lapeyronie
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Emile Muller
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
CHRU - Hotel Dieu
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Centre Antoine Lacassagne Oncologie medicale et Hematologie
City
Nice cedex 1
ZIP/Postal Code
06050
Country
France
Facility Name
Hopital de lArchet 1
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
CH La Source
City
Orleans
ZIP/Postal Code
45000
Country
France
Facility Name
Hopital Cochin
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU Hôpital St-Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHRU - Hopital du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CU CHU Clemenceau
City
Poitiers cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Hopital R. Debre
City
Reims cedex
ZIP/Postal Code
51032
Country
France
Facility Name
CHU Reims - Hôpital Maison Blanche
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHRU Hopital sud Medecine Interne
City
Rennes cedex 02
ZIP/Postal Code
35056
Country
France
Facility Name
CHRU Hôpital de Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
CHG Rodez
City
Rodez
ZIP/Postal Code
12027
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen cedex
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancerologie de Loire
City
St Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Centre Hospitalier Yves Le Foll
City
St-Brieuc cedex 1
ZIP/Postal Code
22027
Country
France
Facility Name
CHRU Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHRU Hopital Purpan
City
Toulouse cedex 9
ZIP/Postal Code
TSA 40031-31059
Country
France
Facility Name
CHRU Hopital Bretonneau
City
Tours cedex
ZIP/Postal Code
37044
Country
France
Facility Name
CHRU Hopital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHRU Hôpitaux de Brabois
City
Vandoeuvre Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
CH P. Chubert
City
Vannes cedex
ZIP/Postal Code
56017
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Medizinische Kinik und Poliklinik I
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitatsklinikum Essen-
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Staedtische Kliniken Frankfurt am Main Hochst
City
Frankfurt am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitatsklinikum Giessen
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
Askepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik II
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitatsklinikum schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Poliklinik A
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang-Goethe-Universtat
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Medizinische Klinik III Klinikum der Universität München-Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Medizinische Fakultat der Universitat Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
City
Stuttgart
ZIP/Postal Code
D -70376
Country
Germany
Facility Name
Medizinische Klinik - Abteilung II
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinik fur Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Alexandra Hospital, University of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Attiko Hospital of Athens
City
Athens
ZIP/Postal Code
124
Country
Greece
Facility Name
Evangelismos Hospital of Athens
City
Athens
Country
Greece
Facility Name
University of Athens
City
Athens
Country
Greece
Facility Name
Metaxa Hospital Peiraias
City
Piraeus
ZIP/Postal Code
18537
Country
Greece
Facility Name
Theagenio Anticancer Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
540 07
Country
Greece
Facility Name
Adelaide and Meath Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Mater Misercordiae Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
ZIP/Postal Code
ST46QG
Country
Ireland
Facility Name
Policlinico S. Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Oncologia Medica, Università della Magna Grecia
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Clinica Ematologica, A.O.U. San Martino di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Unità Operativa di Oncoematologia, Ospedale di Matera
City
Matera
ZIP/Postal Code
75100
Country
Italy
Facility Name
U.O. di Ematologia e Trapianto di Midollo Osseo
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo di Oncologia - IEO
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Presidio Ospedaliero A. Perrino
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Casa di Cura La Maddalena, Divisione di Ematologia
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Policlinico San Matteo Universita Di Pavia
City
Pavia 2
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Civile
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center 3056-6
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Hwasun Chonnam National University Hospital
City
Hwasun-goon
ZIP/Postal Code
519-803
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital 42
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seongsanno
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul - Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Hospital de Sao Marcos
City
Braga
Country
Portugal
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Instituto Portugues de Oncologia de Lisboa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Português de Oncologia Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital de Santo Antonio- Porto
City
Porto
Country
Portugal
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona (Barcelona)
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Instituto Catalan de Oncologia-Hospital Duran
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Univ. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital General Universitario Morales Messeguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Clinico Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
ZIP/Postal Code
7198
Country
Spain
Facility Name
Clinica Universitaria de Navarra,
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Sant Pau
City
Reus
ZIP/Postal Code
43201
Country
Spain
Facility Name
Hospital de Donosti
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universtario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinico Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hosptial La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Linkoping University Hospital
City
Linkoping
ZIP/Postal Code
SE 581 85
Country
Sweden
Facility Name
Karolinska University HospitalSolna
City
Stockholm
ZIP/Postal Code
SE 17176
Country
Sweden
Facility Name
St. Görans Hospital
City
Stockholm
ZIP/Postal Code
SE- 11281
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
SE-14186
Country
Sweden
Facility Name
Abteilung Onkologie Haematologie des Kantonsspitals Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
UniversitatsSpital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselsspital Bern
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital Graubunden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois CHUV
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Munsterlingen
City
Münsterlingen (TG)
ZIP/Postal Code
8596
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Veteran General Hospital - Taipei
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Tapei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Gwynedd Hospital
City
Bangor
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Belfast City Hospital Haematology Department
City
Belfast Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Birminghman QE
City
Birmingham West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Royal Bournemouth Hosp
City
Bournemouth Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
University Hospital of Wales - Cardiff
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
The Beatson West of Scotland Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Dept of Haematology St Bartholomews Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospital - London
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Churchhill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LI
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth Crownhill Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Pinderfields General Hospital
City
West Yorkshire
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
New Cross Hospital- Wolverhampton
City
Wolverhampton
ZIP/Postal Code
WV10 OPQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26659916
Citation
Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.
Results Reference
background
PubMed Identifier
27325857
Citation
Hulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.
Results Reference
background
PubMed Identifier
25769541
Citation
Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.
Results Reference
background
PubMed Identifier
25184863
Citation
Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
Results Reference
background
PubMed Identifier
28641472
Citation
Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.
Results Reference
background
PubMed Identifier
29784907
Citation
Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.
Results Reference
background
PubMed Identifier
29980678
Citation
Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.
Results Reference
background
PubMed Identifier
30244101
Citation
Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.
Results Reference
background
PubMed Identifier
29150421
Citation
Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.
Results Reference
background
PubMed Identifier
30773308
Citation
Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.
Results Reference
background
PubMed Identifier
30859608
Citation
Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.
Results Reference
background
PubMed Identifier
28373701
Citation
Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.
Results Reference
result
PubMed Identifier
28106903
Citation
Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.
Results Reference
result
Links:
URL
http://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/clinical-study-report-csr-synopses/purposes-of-posting-clinical-study-report-csr-synopses
Description
Link to CSR synopsis

Learn more about this trial

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma

We'll reach out to this number within 24 hrs