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A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Ixazomib

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug Therapy

Eligibility Criteria

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

Inclusion Criteria:

Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.
Female participants who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
Must meet the following clinical laboratory criteria at study entry:
- Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubic millimeter (/mm^3) without growth factor support and platelet count ≥75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization.
- Total bilirubin less than or equal to (≤) 1.5*the upper limit of the normal range (ULN).
- Alanine aminotransferase and aspartate aminotransferase ≤ 3*ULN.
- Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation).

Exclusion Criteria:

Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.
Prior SCT.
Radiotherapy within 14 days before randomization.
Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
Major surgery within 14 days before randomization.
Central nervous system involvement.
Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.
Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).
Psychiatric illness or social situation that would limit compliance with study requirements.
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
Treatment with any investigational products within 30 days before randomization.

Sites / Locations

Robert A Moss MD FACP Inc
UCLA Medical Hematology and Oncology
North County Oncology Medical Clinic Inc
Ventura County Hematology Oncology Specialists
Emad Ibrahim, MD, Inc
Global Cancer Research Institute (GCRI), Inc.
Central Coast Medical Oncology Corporation
Winship Cancer Institute, Emory University
John H. Stroger Jr. Hospital of Cook County
Siouxland Hematology - Oncology Associates LLP
Appalachian Regional Healthcare
New England Cancer Specialists
Saint Agnes Hospital - Baltimore - Hunt - PPDS
University Hospital of Wales -
Tufts Medical Center - PPDS
Herbert-Herman Cancer Center
Clinical Research Alliance Inc
New York Presbyterian Hospital - Weill-Cornell
Cancer Care of WNC PA
UPMC Cancer Pavillion
HOPE Cancer Center of East Texas
Swedish Cancer Institute
W VA University Mary Babb Randolph Cancer Center
Hospital Universitario Austral
Hospital Italiano de Buenos Aires
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Sanatorio Allende S.A.
Hospital Iturraspe
St Vincents Hospital Melbourne - PPDS
Frankston Hospital
The Alfred Hospital
Universitatsklinikum Innsbruck
Paracelsus Medizinische Privatuniversitat
Klinikum Wels-Grieskirchen GmbH
Medizinische Universitat Wien (Medical University of Vienna)
Universitair Ziekenhuis Brussel - PIN
UZ Brussel
Cliniques Universitaires Saint-Luc
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet
Hospital Das Clinicas Da Universidade Federal de Goias
Hospital Das Clinicas Da UFMG
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Liga Norte Riograndense Contra O Cancer
Universidade de Caxias do Sul
Associacao Hospital de Caridade Ijui
American Oncology Partners of Maryland, PA
Hospital Moinhos de Vento
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Mae de Deus Center Hospital Giovanni Battista
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Instituto Joinvilense de Hematologia E Oncologia
Fundacao PIO XII
Universidade Estadual de Campinas
Hospital Amaral Carvalho
Faculdade de Medicina Do ABC
HEMORIO - Unidade de Pesquisa Clinica
Instituto Nacional de Cancer
Fundação Antônio Prudente - AC Camargo Câncer Center
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Instituto de Ensino E Pesquisa Sao Lucas
Hospital Sirio Libanes
Ealing Hospital
Clinica Sao Germano
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Hospital Israelita Albert Einstein
Hospital Santa Marcelina
Royal Victoria Regional Health Centre
William Osler Health Centre
Princess Margaret Hospital
McGill University Health Center
Hospital Amaral Carvalho
Instituto Nacional Del Cancer
Centro Internacional de Estudios Clinicos
Centro de Investigaciones Clinicas Vina del Mar
Hospital de Clinicas de Passo Fundo
Ruijin Hospital Shanghai Jiaotong University School of Medicine
The First Affiliated Hospital, College of Medicine, Zhejiang University
Beijing Chaoyang Hospital Capital Medical University
Peking University Third Hospital
Peking Union Medical College Hospital
The First Affiliated Hospital, College of Medicine, Zhejiang University
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai Chang Zheng Hospital
Hospital São Rafael
Second Hospital of Shanxi Medical University
James Lind Centro de Investigación del Cáncer
Hospital Pablo Tobon Uribe
Instituto Nacional de Cancerologia Colombia
Hospital Universitario San Ignacio
Clinical Hospital Dubrava
Clinical Hospital Center Rijeka
Clinical Hospital Center Zagreb - PPDS
Fakultni nemocnice Hradec Kralove
Fakultni nemocnice Kralovske Vinohrady
Fakultni nemocnice Brno
Fakultni nemocnice Olomouc
Fakultni nemocnice Ostrava
Vseobecna fakultni nemocnice v Praze
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Aarhus Universitetshospital Århus Sygehus
Regionshospitalet Holstebro
Odense Universitetshospital
Hopital Antoine Beclere
Hotel Dieu
CHRU Nancy
CHRU Dijon Complexe Du Bocage
Hopital Saint Vincent de Paul GHICL
CHRU Lille
Hopital de la Pitie Salpetriere
Groupe Hospitalier Necker Enfants Malades
Hopital Haut Leveque
Hopital Jean Bernard
CHRU Rennes
Universitatsklinikum Ulm
Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH
Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
Internistisch Hamatologische und Internistische Praxis
LMU Klinikum der Universitat Munchen
Pius Hospital Oldenburg
Universitatsklinikum Essen
Gemeinschaftspraxis fur Hamatologie und Onkologie
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Universitat Des Saarlandes
Onkologie Aschaffenburg
Charite - Universitatsmedizin Berlin
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt
Klinikum Landshut
Klinikum rechts der Isar der Technischen Universitat Munchen
Praxis Pihusch Medizinisches Versorgungszentrum GbR
Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas
University of Athens Medical School - Regional General Hospital Alexandra
Evangelismos General Hospital of Athens
University General Hospital of Ioannina
University General Hospital of Larissa
Theageneio Anticancer Oncology Hospital of Thessaloniki
Georgios Papanikolaou General Hospital of Thessaloniki
Semmelweis Egyetem
Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy
Debreceni Egyetem Klinikai Kozpont
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Shamir Medical Center Assaf Harofeh
Rigshospitalet
Bnai Zion Medical Center
Hadassah Medical Center - PPDS
Meir Medical Center
Rabin Medical Center - PPDS
Chaim Sheba Medical Center
Tel Aviv Sourasky Medical Center
Assuta Medical Centers
Baruch Padeh Poriya Medical Center
AORN A Cardarelli
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Ospedale Infermi di Rimini
IRCCS Az. Osp. Universitaria San Martino- IST
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Ospedale Casa Sollievo Della Sofferenza IRCCS
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Azienda Ospedaliero Universitaria Pisana
Azienda Ospedaliera S Maria Di Terni
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Azienda Ospedaliera Universitaria Careggi
Azienda Ospedaliero Universitaria di Parma
Ospedale Santa Maria Delle Croci
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Ogaki Municipal Hospital
Kobe City Medical Center General Hospital
Hitachi General Hospital
Nara Hospital Kinki University Faculty of Medicine
National Hospital Organization Okayama Medical Center
Juntendo University Hospital
Japanese Red Cross Medical Center
National Hospital Organization Kyushu Medical Center
Fukushima Medical University Hospital
National Hospital Organization Mito Medical Center
Kurume University Hospital
Shizuoka Cancer Center
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya City University Hospital
Japanese Red Cross Narita Hospital
Niigata Cancer Center Hospital
Osaka Saiseikai Nakatsu Hospital
National Hospital Organization Disaster Medical Center
Toyohashi Municipal Hospital
Yamanashi Prefectural Central Hospital
National Cancer Center
Gachon University Gil Medical Center
Seoul National University Hospital
Severance Hospital Yonsei University Health System - PPDS
Samsung Medical Center - PPDS
The Catholic University of Korea, Seoul St. Mary's Hospital
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
Hospital Y Clinica OCA Sociedad Anonima de Capital Variable
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Oaxaca Site management Organization (OSMO) - PPDS
Shengjing Hospital of China Medical University
MTZ Clinical Research Sp z o o - PRATIA - PPDS
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Hospital Garcia de Orta
Hospital de Braga
Champalimaud Cancer Center
Centro Hospitalar do Porto - Hospital de Santo Antonio
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Centro Hospitalar de Sao Joao EPE
State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary
Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate
Ryazan Regional Clinical Hospital
Russian Research Institute of Hematology and Blood Transfusion
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Clinical Hospital Center ''Bezanijska Kosa''
University Clinical Center Kragujevac
Soroka University Medical Centre
National University Hospital
Singapore General Hospital (SGH)
Medical Oncology Centre of Rosebank
Albert Alberts Stem Cell Transplant Centre
Mary Potter Oncology Centre
Hospital Universitario Germans Trias i Pujol
Hospital Universitario Quironsalud Madrid
Clinica Universidad Navarra
Hospital Clinic de Barcelona
Hospital de La Santa Creu i Sant Pau
Hospital Universitario de La Princesa
Hospital General Universitario Gregorio Maranon
Hospital Universitario Infanta Leonor
Hospital Universitario La Paz
Hospital Universitario HM Sanchinarro CIOCC
Hospital General Universitario Morales Meseguer
Complejo Asistencial Universitario de Salamanca H. Clinico
Hospital Universitari i Politecnic La Fe de Valencia
Karolinska Universitetssjukhuset Huddinge
Karolinska Universitetssjukhuset Solna
Sahlgrenska Universitetssjukhuset
Skanes Universitetssjukhus Lund
Spital STS AG
Kaohsiung Medical University Hospital
Taichung Veterans General Hospital
National Taiwan University Hospital
Ramathibodi Hospital
Chulalongkorn University
Maharaj Nakorn Chiang Mai Chiang Mai University
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara University Medical Faculty PPDS
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Dokuz Eylul University Medical Faculty
Belfast City Hospital
Birmingham Heartlands Hospital
Bristol Haematology and Oncology Centre
Royal Bournemouth Hospital
Queen Alexandra Hospital
Kent and Canterbury Hospital
Barts Health NHS Trust
University College London
Kings College Hospital
Hammersmith Hospital
Hillingdon Hospital
Churchill Hospital
New Cross Hospital
Royal Marsden Hospital - Surrey
Royal United Hospital
Ulster Hospital
Southmead Hospital
University Clinical Center Nis
West Middlesex University Hospital
Leicester Royal Infirmary
Chelsea and Westminster NHS Trust
Manchester Royal Infirmary - PPDS
Northwick Park Hospital
The Royal Oldham Hospital - PPDS
University Clinical Center of Serbia - PPDS
Singleton Hospital - PPDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ixazomib

Arm Description

Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/ deciliter (dL)); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved free light chains (FLC) levels (absolute increase >10 mg/dL); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia (corrected serum calcium >11.5mg/dL).

Secondary Outcome Measures

Overall Survival (OS)

OS was measured as the time from the date of randomization to the date of death.

Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period

Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= >=50% reduction of serum M protein and >=90% or <200 mg reduction urinary M protein in 24-hour, or >50% decrease in difference between involved and uninvolved FLC levels, or >50% reduction in bone marrow plasma cells, if bone marrow plasma cells >30% and >50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= >90% reduction (<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= >5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.

Time to Progression (TTP)

TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.

Progression Free Survival 2 (PFS2)

PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.

Time to Next Line Therapy (TTNT)

TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.

Time to End of the Next-line of Therapy After Study Treatment

Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment.

Duration of Next-line Therapy

Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.

Percentage of Participants Who Develop a New Primary Malignancy

Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative

Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry. MRD negativity was defined as absence of MRD and MRD positivity was defined as presence of MRD. MRD was assessed by 8-color flow cytometry with the IMWG recommended sensitivity of 10^-5.

Correlation of MRD Status With PFS and OS

PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.

OS in a High-risk Population

High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation [t](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.

PFS in a High-risk Population

High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.

Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs were defined as events that occurred after administration of the first dose of ixazomib or placebo through 30 days after the last dose of ixazomib or placebo. A SAE means any untoward medical occurrence that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was considered medically significant.

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.

Correlation Between Frailty Status and PFS and OS

Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure.

Pharmacokinetic Parameter: Plasma Concentration of Ixazomib

Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay.

Time to Resolution of Peripheral Neuropathy (PN) Events

PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.

Time to Improvement of PN Events

PN is defined as the event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the improvement date or the day before and after. Time to improvement was defined as the time from the initial onset date (inclusive) to the improvement of event.

Full Information

NCT ID

NCT02312258

First Posted

December 5, 2014

Last Updated

August 23, 2023

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT02312258

Brief Title

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Official Title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 9, 2015 (Actual)

Primary Completion Date

August 12, 2019 (Actual)

Study Completion Date

August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

Detailed Description

The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival. The study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): Ixazomib citrate initiates at 3 mg which will be escalated to 4 mg with cycle 5 day 1 Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

706 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Arm Title

Ixazomib

Arm Type

Experimental

Arm Description

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Ixazomib placebo-matching capsules.

Intervention Type

Drug

Intervention Name(s)

Ixazomib

Intervention Description

Ixazomib capsules.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From randomization until PD or death (up to 52 months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS was measured as the time from the date of randomization to the date of death.

Time Frame

From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)

Title

Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period

Description

Time Frame

Up to 27 months

Title

Time to Progression (TTP)

Description

TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.

Time Frame

From randomization until PD or death (up to 52 months)

Title

Progression Free Survival 2 (PFS2)

Description

PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.

Time Frame

From the date of randomization to every 12 weeks until second PD or death (up to 88 months)

Title

Time to Next Line Therapy (TTNT)

Description

TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.

Time Frame

From randomization until PD or death (up to 52 months)

Title

Time to End of the Next-line of Therapy After Study Treatment

Description

Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment.

Time Frame

From randomization until PD or death (up to 52 months)

Title

Duration of Next-line Therapy

Description

Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.

Time Frame

From randomization until PD or death (up to 52 months)

Title

Percentage of Participants Who Develop a New Primary Malignancy

Time Frame

From randomization until PD or death (up to 52 months)

Title

Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative

Description

Time Frame

Up to 52 months

Title

Correlation of MRD Status With PFS and OS

Description

Time Frame

From randomization up to 52 months

Title

OS in a High-risk Population

Description

Time Frame

From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)

Title

PFS in a High-risk Population

Description

Time Frame

From randomization until PD or death (up to 52 months)

Title

Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

Description

Time Frame

Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)

Title

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Description

Time Frame

First dose of study drug through 30 days after last dose of study drug (up to 88 months)

Title

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)

Description

Time Frame

Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)

Title

Correlation Between Frailty Status and PFS and OS

Description

Time Frame

From randomization up to 52 months

Title

Pharmacokinetic Parameter: Plasma Concentration of Ixazomib

Description

Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay.

Time Frame

Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)

Title

Time to Resolution of Peripheral Neuropathy (PN) Events

Description

Time Frame

Up to 52 months

Title

Time to Improvement of PN Events

Description

Time Frame

Up to 52 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria. Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached. Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy. Female participants who: Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (that is, status postvasectomy), who: Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available. Eastern Cooperative Oncology Group Performance Status of 0 to 2. Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken. Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration. Must meet the following clinical laboratory criteria at study entry: Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubic millimeter (/mm^3) without growth factor support and platelet count ≥75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization. Total bilirubin less than or equal to (≤) 1.5*the upper limit of the normal range (ULN). Alanine aminotransferase and aspartate aminotransferase ≤ 3*ULN. Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation). Exclusion Criteria: Multiple myeloma that has relapsed after, or was not responsive to, initial therapy. Prior SCT. Radiotherapy within 14 days before randomization. Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period. Major surgery within 14 days before randomization. Central nervous system involvement. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization. Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection. Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause). Psychiatric illness or social situation that would limit compliance with study requirements. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment. Treatment with any investigational products within 30 days before randomization.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Robert A Moss MD FACP Inc

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

UCLA Medical Hematology and Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

North County Oncology Medical Clinic Inc

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Ventura County Hematology Oncology Specialists

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Emad Ibrahim, MD, Inc

City

Redlands

State/Province

California

ZIP/Postal Code

92373

Country

United States

Facility Name

Global Cancer Research Institute (GCRI), Inc.

City

San Jose

State/Province

California

ZIP/Postal Code

95124

Country

United States

Facility Name

Central Coast Medical Oncology Corporation

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Winship Cancer Institute, Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

John H. Stroger Jr. Hospital of Cook County

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Siouxland Hematology - Oncology Associates LLP

City

Sioux City

State/Province

Iowa

ZIP/Postal Code

51101

Country

United States

Facility Name

Appalachian Regional Healthcare

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

New England Cancer Specialists

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Saint Agnes Hospital - Baltimore - Hunt - PPDS

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

University Hospital of Wales -

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Tufts Medical Center - PPDS

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Herbert-Herman Cancer Center

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

Clinical Research Alliance Inc

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

New York Presbyterian Hospital - Weill-Cornell

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Cancer Care of WNC PA

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

UPMC Cancer Pavillion

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

HOPE Cancer Center of East Texas

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Facility Name

Swedish Cancer Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

W VA University Mary Babb Randolph Cancer Center

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Hospital Universitario Austral

City

Buenos Aires

State/Province

Ciudad Autonoma De BuenosAires

ZIP/Postal Code

B1629AHJ

Country

Argentina

Facility Name

Hospital Italiano de Buenos Aires

City

Buenos Aires

State/Province

Ciudad Autonoma De BuenosAires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

City

Buenos Aires

State/Province

Ciudad Autonoma De BuenosAires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Sanatorio Allende S.A.

City

Cordoba

ZIP/Postal Code

X5000JHQ

Country

Argentina

Facility Name

Hospital Iturraspe

City

Santa Fe

ZIP/Postal Code

S3000ADL

Country

Argentina

Facility Name

St Vincents Hospital Melbourne - PPDS

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Frankston Hospital

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

The Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Universitatsklinikum Innsbruck

City

Innsbruck

State/Province

Tirol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Paracelsus Medizinische Privatuniversitat

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Klinikum Wels-Grieskirchen GmbH

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Medizinische Universitat Wien (Medical University of Vienna)

City

Wien

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Universitair Ziekenhuis Brussel - PIN

City

Brussel

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

UZ Brussel

City

Brussel

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Cliniques Universitaires Saint-Luc

City

Bruxelles

State/Province

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

City

Salvador

State/Province

Bahia

ZIP/Postal Code

41253-196

Country

Brazil

Facility Name

Hospital Das Clinicas Da Universidade Federal de Goias

City

Goiania

State/Province

Goias

ZIP/Postal Code

74605-020

Country

Brazil

Facility Name

Hospital Das Clinicas Da UFMG

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

City

Curitiba

State/Province

Parana

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Liga Norte Riograndense Contra O Cancer

City

Natal

State/Province

Rio Grande Do Norte

ZIP/Postal Code

59040-150

Country

Brazil

Facility Name

Universidade de Caxias do Sul

City

Caxias Do Sul

State/Province

Rio Grande Do Sul

ZIP/Postal Code

95070-560

Country

Brazil

Facility Name

Associacao Hospital de Caridade Ijui

City

Ijui

State/Province

Rio Grande Do Sul

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

American Oncology Partners of Maryland, PA

City

Passo Fundo

State/Province

Rio Grande Do Sul

ZIP/Postal Code

99010-260

Country

Brazil

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-001

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Mae de Deus Center Hospital Giovanni Battista

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90470-340

Country

Brazil

Facility Name

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Instituto Joinvilense de Hematologia E Oncologia

City

Joinville

State/Province

Santa Catarina

ZIP/Postal Code

89201260

Country

Brazil

Facility Name

Fundacao PIO XII

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Universidade Estadual de Campinas

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083-878

Country

Brazil

Facility Name

Hospital Amaral Carvalho

City

Jau

State/Province

Sao Paulo

ZIP/Postal Code

17210-120

Country

Brazil

Facility Name

Faculdade de Medicina Do ABC

City

Santo Andre

State/Province

Sao Paulo

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

HEMORIO - Unidade de Pesquisa Clinica

City

Rio De Janeiro

ZIP/Postal Code

20211-030

Country

Brazil

Facility Name

Instituto Nacional de Cancer

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Fundação Antônio Prudente - AC Camargo Câncer Center

City

Rio De Janeiro

ZIP/Postal Code

21941-913

Country

Brazil

Facility Name

Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto

City

Sao Jose Do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Instituto de Ensino E Pesquisa Sao Lucas

City

Sao Paulo

ZIP/Postal Code

01236-030

Country

Brazil

Facility Name

Hospital Sirio Libanes

City

Sao Paulo

ZIP/Postal Code

01308-050

Country

Brazil

Facility Name

Ealing Hospital

City

Sao Paulo

ZIP/Postal Code

01509-900

Country

Brazil

Facility Name

Clinica Sao Germano

City

Sao Paulo

ZIP/Postal Code

04537-080

Country

Brazil

Facility Name

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

City

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Hospital Israelita Albert Einstein

City

Sao Paulo

ZIP/Postal Code

05652-900

Country

Brazil

Facility Name

Hospital Santa Marcelina

City

Sao Paulo

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

Royal Victoria Regional Health Centre

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

William Osler Health Centre

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6W 3J7

Country

Canada

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

McGill University Health Center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Hospital Amaral Carvalho

City

Temuco

State/Province

Araucanía

ZIP/Postal Code

4800827

Country

Chile

Facility Name

Instituto Nacional Del Cancer

City

Santiago

ZIP/Postal Code

8380455

Country

Chile

Facility Name

Centro Internacional de Estudios Clinicos

City

Santiago

Country

Chile

Facility Name

Centro de Investigaciones Clinicas Vina del Mar

City

Vina Del Mar

ZIP/Postal Code

2570017

Country

Chile

Facility Name

Hospital de Clinicas de Passo Fundo

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Ruijin Hospital Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

The First Affiliated Hospital, College of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Beijing Chaoyang Hospital Capital Medical University

City

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Peking University Third Hospital

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

Facility Name

The First Affiliated Hospital, College of Medicine, Zhejiang University

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

Renji Hospital Shanghai Jiaotong University School of Medicine

City

Shanghai

ZIP/Postal Code

200001

Country

China

Facility Name

Shanghai Chang Zheng Hospital

City

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Hospital São Rafael

City

Shenyang

ZIP/Postal Code

110004

Country

China

Facility Name

Second Hospital of Shanxi Medical University

City

Taiyuan

ZIP/Postal Code

030001

Country

China

Facility Name

James Lind Centro de Investigación del Cáncer

City

Wuhan

ZIP/Postal Code

430030

Country

China

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Instituto Nacional de Cancerologia Colombia

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Hospital Universitario San Ignacio

City

Bogota

State/Province

Distrito Capital De Bogota

ZIP/Postal Code

110311

Country

Colombia

Facility Name

Clinical Hospital Dubrava

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Clinical Hospital Center Rijeka

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Clinical Hospital Center Zagreb - PPDS

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Fakultni nemocnice Hradec Kralove

City

Hradec Kralove

State/Province

Kralovehradeck Kraj

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Fakultni nemocnice Kralovske Vinohrady

City

Prague

State/Province

Praha, Hlavni Mesto

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Fakultni nemocnice Brno

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

City

København

State/Province

Capital

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Aarhus Universitetshospital Århus Sygehus

City

Aarhus N

ZIP/Postal Code

DK-8200

Country

Denmark

Facility Name

Regionshospitalet Holstebro

City

Holstebro

ZIP/Postal Code

7500

Country

Denmark

Facility Name

Odense Universitetshospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Hopital Antoine Beclere

City

Clamart

State/Province

Hauts-de-Seine

ZIP/Postal Code

92140

Country

France

Facility Name

Hotel Dieu

City

Nantes

State/Province

Loire-Atlantique

ZIP/Postal Code

44093

Country

France

Facility Name

CHRU Nancy

City

Vandoeuvre-les-nancy

State/Province

Meurthe-et-Moselle

ZIP/Postal Code

54511

Country

France

Facility Name

CHRU Dijon Complexe Du Bocage

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Hopital Saint Vincent de Paul GHICL

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

CHRU Lille

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hopital de la Pitie Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Groupe Hospitalier Necker Enfants Malades

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Hopital Haut Leveque

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Hopital Jean Bernard

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

CHRU Rennes

City

Rennes

Country

France

Facility Name

Universitatsklinikum Ulm

City

Ulm

State/Province

Baden-Wurttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH

City

Villingen-Schwenningen

State/Province

Baden-Wurttemberg

ZIP/Postal Code

78050

Country

Germany

Facility Name

Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter

City

Augsburg

State/Province

Bayern

ZIP/Postal Code

86150

Country

Germany

Facility Name

Internistisch Hamatologische und Internistische Praxis

City

Herrsching am Ammersee

State/Province

Bayern

ZIP/Postal Code

82211

Country

Germany

Facility Name

LMU Klinikum der Universitat Munchen

City

Munchen

State/Province

Bayern

ZIP/Postal Code

81377

Country

Germany

Facility Name

Pius Hospital Oldenburg

City

Oldenburg

State/Province

Niedersachsen

ZIP/Postal Code

26121

Country

Germany

Facility Name

Universitatsklinikum Essen

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Gemeinschaftspraxis fur Hamatologie und Onkologie

City

Munster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitat Des Saarlandes

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

Onkologie Aschaffenburg

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Charite - Universitatsmedizin Berlin

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Medizinisches Versorgungszentrum Onkologischer Schwerpunkt

City

Berlin

ZIP/Postal Code

14195

Country

Germany

Facility Name

Klinikum Landshut

City

Landshut

ZIP/Postal Code

84034

Country

Germany

Facility Name

Klinikum rechts der Isar der Technischen Universitat Munchen

City

Munchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Praxis Pihusch Medizinisches Versorgungszentrum GbR

City

Rosenheim

ZIP/Postal Code

83022

Country

Germany

Facility Name

Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas

City

Wurzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

University of Athens Medical School - Regional General Hospital Alexandra

City

Athens

State/Province

Attiki

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Evangelismos General Hospital of Athens

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

University General Hospital of Ioannina

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

University General Hospital of Larissa

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Theageneio Anticancer Oncology Hospital of Thessaloniki

City

Thessaloniki

ZIP/Postal Code

54007

Country

Greece

Facility Name

Georgios Papanikolaou General Hospital of Thessaloniki

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Semmelweis Egyetem

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Shamir Medical Center Assaf Harofeh

City

Be'er Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Rigshospitalet

City

Beer Yaakov

ZIP/Postal Code

70300

Country

Israel

Facility Name

Bnai Zion Medical Center

City

Haifa

ZIP/Postal Code

33394

Country

Israel

Facility Name

Hadassah Medical Center - PPDS

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Meir Medical Center

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Rabin Medical Center - PPDS

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Chaim Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Assuta Medical Centers

City

Tel Aviv

ZIP/Postal Code

69710

Country

Israel

Facility Name

Baruch Padeh Poriya Medical Center

City

Tiberias

ZIP/Postal Code

15208

Country

Israel

Facility Name

AORN A Cardarelli

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Ospedale Infermi di Rimini

City

Rimini

State/Province

Emilia-Romagna

ZIP/Postal Code

47900

Country

Italy

Facility Name

IRCCS Az. Osp. Universitaria San Martino- IST

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

Country

Italy

Facility Name

Ospedale Casa Sollievo Della Sofferenza IRCCS

City

San Giovanni Rotondo

State/Province

Puglia

ZIP/Postal Code

71013

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95124

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Pisana

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56216

Country

Italy

Facility Name

Azienda Ospedaliera S Maria Di Terni

City

Terni

State/Province

Umbria

ZIP/Postal Code

05100

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Careggi

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria di Parma

City

Parma

ZIP/Postal Code

43126

Country

Italy

Facility Name

Ospedale Santa Maria Delle Croci

City

Ravenna

ZIP/Postal Code

48100

Country

Italy

Facility Name

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Ogaki Municipal Hospital

City

Ogaki

State/Province

Gihu

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Kobe City Medical Center General Hospital

City

Kobe-City

State/Province

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Hitachi General Hospital

City

Hitachi

State/Province

Ibaraki

ZIP/Postal Code

317-0077

Country

Japan

Facility Name

Nara Hospital Kinki University Faculty of Medicine

City

Ikoma-City

State/Province

Nara

ZIP/Postal Code

630-0293

Country

Japan

Facility Name

National Hospital Organization Okayama Medical Center

City

Okayama-city

State/Province

Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Juntendo University Hospital

City

Bunkyo

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Japanese Red Cross Medical Center

City

Shibuya-ku

State/Province

Tokyo

ZIP/Postal Code

150-8935

Country

Japan

Facility Name

National Hospital Organization Kyushu Medical Center

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

Fukushima Medical University Hospital

City

Fukushima-City

ZIP/Postal Code

960-1295

Country

Japan

Facility Name

National Hospital Organization Mito Medical Center

City

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Kurume University Hospital

City

Kurume

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Shizuoka Cancer Center

City

Nagaizumi-chō

ZIP/Postal Code

4118777

Country

Japan

Facility Name

Japanese Red Cross Nagoya Daiichi Hospital

City

Nagoya

ZIP/Postal Code

453-8511

Country

Japan

Facility Name

Nagoya City University Hospital

City

Nagoya

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Japanese Red Cross Narita Hospital

City

Narita-shi

ZIP/Postal Code

286-8523

Country

Japan

Facility Name

Niigata Cancer Center Hospital

City

Niigata-city

Country

Japan

Facility Name

Osaka Saiseikai Nakatsu Hospital

City

Osaka

ZIP/Postal Code

530-0012

Country

Japan

Facility Name

National Hospital Organization Disaster Medical Center

City

Tachikawa

ZIP/Postal Code

1900014

Country

Japan

Facility Name

Toyohashi Municipal Hospital

City

Toyohashi

Country

Japan

Facility Name

Yamanashi Prefectural Central Hospital

City

Yamanashi

ZIP/Postal Code

400-8506

Country

Japan

Facility Name

National Cancer Center

City

Goyang-si

State/Province

Gyeonggido

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Gachon University Gil Medical Center

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Severance Hospital Yonsei University Health System - PPDS

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Samsung Medical Center - PPDS

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Hospital Y Clinica OCA Sociedad Anonima de Capital Variable

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Hospital Universitario Dr. Jose Eleuterio Gonzalez

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Oaxaca Site management Organization (OSMO) - PPDS

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Shengjing Hospital of China Medical University

City

Bydgoszcz

State/Province

Kujawsko-pomorskie

ZIP/Postal Code

85-168

Country

Poland

Facility Name

MTZ Clinical Research Sp z o o - PRATIA - PPDS

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

City

Chorzow

Country

Poland

Facility Name

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

City

Lisbon

State/Province

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Hospital Garcia de Orta

City

Almada

ZIP/Postal Code

2801-951

Country

Portugal

Facility Name

Hospital de Braga

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Champalimaud Cancer Center

City

Lisboa

ZIP/Postal Code

1400-038

Country

Portugal

Facility Name

Centro Hospitalar do Porto - Hospital de Santo Antonio

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Centro Hospitalar de Sao Joao EPE

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary

City

Kirov

ZIP/Postal Code

610027

Country

Russian Federation

Facility Name

Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

City

Pyatigorsk

ZIP/Postal Code

357500

Country

Russian Federation

Facility Name

Ryazan Regional Clinical Hospital

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Russian Research Institute of Hematology and Blood Transfusion

City

St. Petersburg

ZIP/Postal Code

193024

Country

Russian Federation

Facility Name

City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

City

St. Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Hospital Center ''Bezanijska Kosa''

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

University Clinical Center Kragujevac

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Soroka University Medical Centre

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Singapore General Hospital (SGH)

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Medical Oncology Centre of Rosebank

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Albert Alberts Stem Cell Transplant Centre

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0044

Country

South Africa

Facility Name

Mary Potter Oncology Centre

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Hospital Universitario Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitario Quironsalud Madrid

City

Pozuelo De Alarcon

State/Province

Madrid, Communidad Delaware

ZIP/Postal Code

28223

Country

Spain

Facility Name

Clinica Universidad Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital de La Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Hospital Universitario de La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Universitario Infanta Leonor

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Universitario HM Sanchinarro CIOCC

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital General Universitario Morales Meseguer

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

Complejo Asistencial Universitario de Salamanca H. Clinico

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe de Valencia

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Karolinska Universitetssjukhuset Huddinge

City

Stockholm

State/Province

Sodermanlands Lan

Country

Sweden

Facility Name

Karolinska Universitetssjukhuset Solna

City

Stockholm

State/Province

Sodermanlands Lan

Country

Sweden

Facility Name

Sahlgrenska Universitetssjukhuset

City

Goteborg

State/Province

Vastra Gotalands Lan

Country

Sweden

Facility Name

Skanes Universitetssjukhus Lund

City

Lund

ZIP/Postal Code

SE-22185

Country

Sweden

Facility Name

Spital STS AG

City

Thun

ZIP/Postal Code

CH-3600

Country

Switzerland

Facility Name

Kaohsiung Medical University Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Ramathibodi Hospital

City

Bangkok

State/Province

Krung Thep Maha Nakhon

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Maharaj Nakorn Chiang Mai Chiang Mai University

City

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Hacettepe Universitesi Tip Fakultesi Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara University Medical Faculty PPDS

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Dokuz Eylul University Medical Faculty

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Belfast City Hospital

City

Belfast

State/Province

Antrim

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

Facility Name

Birmingham Heartlands Hospital

City

West Malling

State/Province

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Bristol Haematology and Oncology Centre

City

Bristol

State/Province

Bristol, City Of

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Royal Bournemouth Hospital

City

Bournemouth

State/Province

Dorset

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Queen Alexandra Hospital

City

Portsmouth

State/Province

Hampshire

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Kent and Canterbury Hospital

City

Canterbury

State/Province

Kent

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Facility Name

Barts Health NHS Trust

City

London

State/Province

London, City Of

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

University College London

City

London

State/Province

London, City Of

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

Kings College Hospital

City

London

State/Province

London, City Of

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Hammersmith Hospital

City

London

State/Province

London, City Of

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

Hillingdon Hospital

City

Uxbridge

State/Province

London, City Of

ZIP/Postal Code

UB8 3NN

Country

United Kingdom

Facility Name

Churchill Hospital

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

New Cross Hospital

City

Wolverhampton

State/Province

Staffordshire

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

Facility Name

Royal Marsden Hospital - Surrey

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Royal United Hospital

City

Bath

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

Ulster Hospital

City

Belfast

ZIP/Postal Code

BT16 1RH

Country

United Kingdom

Facility Name

Southmead Hospital

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

University Clinical Center Nis

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

West Middlesex University Hospital

City

Isleworth

ZIP/Postal Code

TW7 6AF

Country

United Kingdom

Facility Name

Leicester Royal Infirmary

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Chelsea and Westminster NHS Trust

City

London

Country

United Kingdom

Facility Name

Manchester Royal Infirmary - PPDS

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Northwick Park Hospital

City

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

The Royal Oldham Hospital - PPDS

City

Oldham

ZIP/Postal Code

OL1 2JH

Country

United Kingdom

Facility Name

University Clinical Center of Serbia - PPDS

City

Southall

ZIP/Postal Code

UB1 3HW

Country

United Kingdom

Facility Name

Singleton Hospital - PPDS

City

Swansea

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Citations:

PubMed Identifier

33021870

Citation

Dimopoulos MA, Spicka I, Quach H, Oriol A, Hajek R, Garg M, Beksac M, Bringhen S, Katodritou E, Chng WJ, Leleu X, Iida S, Mateos MV, Morgan G, Vorog A, Labotka R, Wang B, Palumbo A, Lonial S; TOURMALINE-MM4 study group. Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial. J Clin Oncol. 2020 Dec 1;38(34):4030-4041. doi: 10.1200/JCO.20.02060. Epub 2020 Oct 6. Erratum In: J Clin Oncol. 2022 Mar 10;40(8):919.

Results Reference

derived

Learn more about this trial

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

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