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Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients (ENDEAVOR)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carfilzomib
Bortezomib
Dexamethasone
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, relapsed multiple myeloma

Eligibility Criteria

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

Inclusion Criteria:

  1. Multiple myeloma with relapsing or progressing disease at study entry.

  2. Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):

    • Serum M-protein ≥ 0.5 g/dL, or
    • Urine M-protein ≥ 200 mg/24 hour, or
    • In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or
    • For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL).
  3. Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
  4. Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
  5. Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
  6. Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
  7. Males and females ≥ 18 years of age.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  9. Adequate hepatic function within 21 days prior to randomization, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
  10. Left ventricular ejection fraction (LVEF) ≥ 40%.
  11. Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
  12. Hemoglobin ≥ 8.0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
  13. Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.

  14. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault:

    [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female.

  15. Written informed consent in accordance with federal, local, and institutional guidelines.
  16. Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  17. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.

Exclusion Criteria:

  1. Multiple Myeloma of IgM subtype.
  2. Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
  3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  4. Plasma cell leukemia or circulating plasma cells ≥ 2 × 10^9/L.
  5. Waldenstrom's Macroglobulinemia.
  6. Patients with known amyloidosis.
  7. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
  8. Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
  9. Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
  10. Immunotherapy within 21 days prior to randomization.
  11. Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
  12. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
  13. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
  14. Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
  15. Patients with known cirrhosis.

  16. Second malignancy within the past 3 years except:

    • adequately treated basal cell or squamous cell skin cancer
    • carcinoma in situ of the cervix
    • prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
    • breast carcinoma in situ with full surgical resection
    • treated medullary or papillary thyroid cancer
  17. Patients with myelodysplastic syndrome.
  18. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
  19. Female patients who are pregnant or lactating.
  20. Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).
  21. Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.
  22. Patients with contraindication to dexamethasone.
  23. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
  24. Ongoing graft-vs-host disease.
  25. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.

Sites / Locations

  • Providence St. Joseph Medical Center
  • UCSD Moore Cancer Center
  • UCLA Medical Center
  • Central Coast Medical Oncology Group
  • Colorado Blood Cancer Institute
  • MAB Oncology/Hematology
  • Palm Beach Cancer Institute
  • Winship Cancer Institute
  • Hematology Oncology of Indiana, PC
  • Center for Cancer and Blood Disorders
  • Associates in Oncology/Hematology PC
  • University of Michigan
  • University of Kansas
  • Hackensack University Medical Ctr
  • Montefiore Medical Center
  • Clinical Research Alliance Inc.
  • Weill Cornell Medical College
  • Wake Forest University Health Sciences, Section on Hematology and Oncology
  • Gabrail Cancer Center
  • The Christ Hospital
  • Western Pennsylvania Hospital
  • Hematology/Oncology Associates of SC
  • Vanderbilt Ingram Cancer Center
  • MD Anderson
  • The Methodist Cancer Center
  • Scott & White Memorial Hospital
  • University of Utah School of Medicine
  • Royal Prince Alfred Hospital
  • St. Vincent's Public Hospital Sydney
  • Saint George Hospital
  • Liverpool Hospital
  • Royal North Shore Hospital
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Royal Brisbane and Women's Hospital
  • Haematology & Oncology Clinics of Australia
  • Haematology and Oncology Clinics of Australia at Chermside
  • Haematology and Oncology Clinics of Australia at Wesley
  • Royal Adelaide Hospital
  • The Queen Elizabeth Hospital
  • Box Hill Hospital
  • Monash Medical Centre
  • Saint Vincent's Hospital
  • Western Hospital
  • The Alfred Hospital
  • Sunshine Hospital
  • Fremantle Hospital
  • Royal Perth Hospital
  • Medizinische Universität Innsbruck
  • Krankenhaus der Elisabethinen Linz, I Interne Abteilung
  • Wilhelminenspital der Stadt Wien
  • Universitair Ziekenhuis Leuven
  • Cliniques Universitaires UCL de Mont-Godinne
  • Universitair Ziekenhuis Gent
  • Ziekenhuis Netwerk Antwerpen
  • Cliniques Universitaires Saint Luc
  • Universitair Ziekenhuis Brussel
  • Liga Norte Riograndense Contra o Câncer
  • Clínica de Oncologia de Porto Alegre
  • Hospital de Clínicas de Porto Alegre
  • Hospital São Lucas da PUCRS
  • Hemocentro Campinas-Unicamp
  • Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
  • Instituto Centros Oncológicos Integrados de Educação e Pesquisa
  • Instituto Nacional do Câncer-INCA
  • Irmandade da Santa Casa de Misericórdia de São Paulo
  • Military Medical Academy Hospital for Active Treatment
  • Shato, Ead
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
  • Multiprofile Hospital for Active Treatment, "Sveta Marina''
  • University of Alberta Hospital
  • British Columbia Cancer Agency
  • Saint John Regional Hospital
  • Queen Elizabeth II Health Science Centre
  • London Health Sciences Centre
  • The Ottawa Hospital Regional Cancer Centre
  • Windsor Regional Hospital
  • Hopital Maisonneuve-Rosemont
  • Fakultní nemocnice Královské Vinohrady
  • Fakultní nemocnice Olomouc
  • FN Ostrava
  • Fakultní nemocnice Hradec Králové
  • Fakultní nemocnice Brno
  • Všeobecná fakultní nemocnice v Praze
  • Centre Hospitalier de la Cote Basque
  • Centre Hospitalier Universitaire Brest
  • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
  • Hopital Hotel-Dieu - Service d'Hematologie
  • Centre Henri-Becquerel
  • Centre Hospitalier de Versailles
  • Hôpital Saint Louis
  • Hôpital Saint-Antoine
  • Hôpital Claude Huriez
  • Hôpital Hôtel-Dieu
  • Institut Paoli Calmettes
  • Centre Hospitalier Lyon Sud
  • Universitätsklinik Heidelberg
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Ulm
  • Medizinische Klinik der Universität Würzburg
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Aachen
  • Universitätsklinikum Münster
  • Universitätsmedizin der Johannes Gutenberg Universität
  • Universitätsklinikum des Saarlandes
  • Klinikum Chemnitz gGmbH
  • Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Jena
  • Universitatsklinikum Freiburg
  • Universitätsklinikum Hamburg Eppendorf
  • Alexandra General Hospital
  • Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
  • Pécsi Tudományegyetem
  • Szegedi Tudományegyetem
  • Debreceni Egyetem Klinikai Központ
  • Egyesített Szent István és Szent László Kórház-Rendelointézet
  • Somogy Megyei Kaposi Mac okato Korhoz
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Rambam Health Corp.
  • Hadassah Medical Center
  • Meir Medical Center
  • Tel Aviv Sourasky Medical Center
  • The Chaim Sheba Medical Center at Tel Hashomer
  • IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
  • Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • Azienda Ospedaliera Spedali Civili di Brescia
  • IRCCS Azienda Ospedaliera Universitaria San Martino
  • Azienda Ospedaliera Universitaria Maggiore della Carità
  • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
  • Azienda Ospedaliera Pisana Ospedale Santa Chiara
  • Aienda Policknico Umberto I di Roma
  • Azienda Policknico Umberto l di Roma
  • Università Tor Vergata Ospedale Sant Eugenio
  • Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Nagoya City University Hospital
  • Toyohashi Municipal Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Ogaki Municipal Hospital
  • Gunma University Hospital
  • National Hospital Organization Nishigunma National Hospital
  • Sapporo Medical University Hospital
  • Kobe City Medical Center General Hospital
  • Tokai University Hospital
  • Niigata Cancer Center Hospital
  • Osaka University Hospital
  • Saitama Medical Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • The Cancer Institute Hospital Of Japanese Foundation For Cancer Research
  • Toranornon Hospital
  • Tokyo Medical University Hospital
  • National Hospital Organization Disaster Medical Center
  • Kyushu University Hospital
  • Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
  • University Hospital, Kyoto Prefectural University of Medicine
  • National Hospital Organization Okayama Medical Center
  • Tokushima Prefectural Central Hospital
  • Japanese Red Cross Medical Center
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Seoul Saint Mary's Hospital
  • Severance Hospital, Yonsei University Health System
  • North Shore Hospital
  • Middlemore Hospital
  • Auckland City Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
  • Zamojski Szpital Niepubliczny Sp. z o.o.
  • Szpital Uniwersytecki w Krakowie
  • Instytut Hematologii i Transfuzjologii
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
  • Spitalul Universitar de Urgenta Bucuresti
  • Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
  • Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
  • Institutul Clinic Fundeni
  • Institutul Regional de Oncologie Iasi
  • Republican Clinical Hospital #1
  • City Clinical Hospital n.a. S. P. Botkin
  • Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
  • Ryazan Regional Clinical Hospital
  • Clinical Hospital Number 31
  • Federal Almazov Medical Research Centre
  • FGU Russian Scientific Research Institute of Hematology and Transfusiology
  • First Saint Petersburg I.P. Pavlov State Medical University
  • GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
  • National University Cancer Institute
  • Singapore General Hospital
  • Singapore Oncology Consultants
  • Univerzitná nemocnica Bratislava
  • Hospital Son Llàtzer
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Clinic I Provincial de Barcelona
  • Institut Universitari Dexeus
  • Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Princesa
  • Hospital Clínico Universitario de Salamanca
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic La Fé de Valencia
  • Chang Gung Memorial Hospital
  • China Medical University Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation-LinKou Branch
  • King Chulalongkorn Memorial Hospital
  • Ramathibodi Hospital
  • Srinagarind Hospital
  • City Hematology Center
  • Municipal Institution of Health Protection "Clinical Hospital #8"
  • Cherkassy Regional Oncology Center
  • MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
  • Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
  • Khmelnytsky Regional Clinical Hospital
  • Khmelnytsky Regional Hospital, Department of Hematology
  • National Institute of Cancer, Oncohematology Department
  • Kyiv Bone Marrow Transplantation Center
  • Lviv Regional Oncology Dispensary
  • Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
  • Regional Clinical Hospital
  • Royal Free Hospital
  • University College Hospital
  • Manchester Royal Infirmary
  • Nottingham University Hospitals NHS Trust
  • Churchill Hospital
  • Derriford Hospital
  • Royal Hallamshire Hospital
  • Royal Marsden Hospital
  • Royal Wolverhampton Hospitals Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carfilzomib plus Dexamethasone

Bortezomib plus Dexamethasone

Arm Description

Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.

Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Outcomes

Primary Outcome Measures

Progression-free Survival
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.

Secondary Outcome Measures

Overall Survival
Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method.
Overall Response
Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR). sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
Duration of Response
Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.
Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)
A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%. For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%.
Change From Baseline in Right Ventricular Fractional Area Change (FAC)
Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.
Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)
Pulmonary artery pressure was measured using transthoracic echocardiogram.

Full Information

First Posted
March 28, 2012
Last Updated
November 10, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01568866
Brief Title
Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
Acronym
ENDEAVOR
Official Title
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2012 (Actual)
Primary Completion Date
November 10, 2014 (Actual)
Study Completion Date
February 5, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, relapsed multiple myeloma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Carfilzomib plus Dexamethasone
Arm Type
Experimental
Arm Description
Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
Arm Title
Bortezomib plus Dexamethasone
Arm Type
Active Comparator
Arm Description
Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
PR-171, Krypolis
Intervention Description
Carfilzomib is administered over 30 minutes as an infusion.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
Time Frame
From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method.
Time Frame
From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.
Title
Overall Response
Description
Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR). sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
Time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
Title
Duration of Response
Description
Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
Time Frame
From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.
Title
Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
Description
Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.
Time Frame
From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
Title
Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)
Description
A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%. For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%.
Time Frame
Baseline and 24 weeks
Title
Change From Baseline in Right Ventricular Fractional Area Change (FAC)
Description
Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.
Time Frame
Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
Title
Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary artery pressure was measured using transthoracic echocardiogram.
Time Frame
Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Multiple myeloma with relapsing or progressing disease at study entry. Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization): Serum M-protein ≥ 0.5 g/dL, or Urine M-protein ≥ 200 mg/24 hour, or In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL). Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment. Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy). Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval). Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial. Males and females ≥ 18 years of age. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. Adequate hepatic function within 21 days prior to randomization, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN. Left ventricular ejection fraction (LVEF) ≥ 40%. Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week. Hemoglobin ≥ 8.0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin. Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault: [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female. Written informed consent in accordance with federal, local, and institutional guidelines. Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP. Exclusion Criteria: Multiple Myeloma of IgM subtype. Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). Plasma cell leukemia or circulating plasma cells ≥ 2 × 10^9/L. Waldenstrom's Macroglobulinemia. Patients with known amyloidosis. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization. Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial. Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow). Immunotherapy within 21 days prior to randomization. Major surgery (excluding kyphoplasty) within 28 days prior to randomization. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization. Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed). Patients with known cirrhosis. Second malignancy within the past 3 years except: adequately treated basal cell or squamous cell skin cancer carcinoma in situ of the cervix prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months breast carcinoma in situ with full surgical resection treated medullary or papillary thyroid cancer Patients with myelodysplastic syndrome. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization. Female patients who are pregnant or lactating. Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib). Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol. Patients with contraindication to dexamethasone. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment. Ongoing graft-vs-host disease. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Providence St. Joseph Medical Center
City
Burbank
State/Province
California
Country
United States
Facility Name
UCSD Moore Cancer Center
City
La Jolla
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Central Coast Medical Oncology Group
City
Santa Maria
State/Province
California
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
Country
United States
Facility Name
MAB Oncology/Hematology
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Hematology Oncology of Indiana, PC
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Associates in Oncology/Hematology PC
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Hackensack University Medical Ctr
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
Clinical Research Alliance Inc.
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
Country
United States
Facility Name
Wake Forest University Health Sciences, Section on Hematology and Oncology
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Hematology/Oncology Associates of SC
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
Country
United States
Facility Name
The Methodist Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
St. Vincent's Public Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Saint George Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Haematology & Oncology Clinics of Australia
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Haematology and Oncology Clinics of Australia at Chermside
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Haematology and Oncology Clinics of Australia at Wesley
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Saint Vincent's Hospital
City
East Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Sunshine Hospital
City
St. Albans
State/Province
Victoria
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tyrol
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
City
Linz
State/Province
Upper Austria
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien
City
Wien
State/Province
Vienna
Country
Austria
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
State/Province
Flemish Brabant
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godinne
City
Yvoir
State/Province
Namur
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
State/Province
Oost-vlaanderen
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen
City
Antwerp
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Liga Norte Riograndense Contra o Câncer
City
Natal
State/Province
RIO Grande DO Norte
Country
Brazil
Facility Name
Clínica de Oncologia de Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
RIO Grande DO SUL
Country
Brazil
Facility Name
Hemocentro Campinas-Unicamp
City
Campinas
State/Province
SAO Paulo
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
Country
Brazil
Facility Name
Instituto Centros Oncológicos Integrados de Educação e Pesquisa
City
Rio de Janeiro
Country
Brazil
Facility Name
Instituto Nacional do Câncer-INCA
City
Rio de Janeiro
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Military Medical Academy Hospital for Active Treatment
City
Sofia
State/Province
Sofiya
Country
Bulgaria
Facility Name
Shato, Ead
City
Sofia
State/Province
Sofiya
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
City
Plovdiv
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment, "Sveta Marina''
City
Varna
Country
Bulgaria
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Queen Elizabeth II Health Science Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Windsor Regional Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Fakultní nemocnice Královské Vinohrady
City
Praha 10
State/Province
Praha
Country
Czechia
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
State/Province
Severomoravsky KRAJ
Country
Czechia
Facility Name
FN Ostrava
City
Ostrava
State/Province
Severomoravsky KRAJ
Country
Czechia
Facility Name
Fakultní nemocnice Hradec Králové
City
Hradec Kralové
State/Province
Vychodocesky KRAJ
Country
Czechia
Facility Name
Fakultní nemocnice Brno
City
Brno
Country
Czechia
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha
Country
Czechia
Facility Name
Centre Hospitalier de la Cote Basque
City
Bayonne
State/Province
Aquitaine
Country
France
Facility Name
Centre Hospitalier Universitaire Brest
City
Brest Cedex
State/Province
Bretagne
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
City
Rennes Cedex 9
State/Province
Bretagne
Country
France
Facility Name
Hopital Hotel-Dieu - Service d'Hematologie
City
Nantes
State/Province
Cedex 1
Country
France
Facility Name
Centre Henri-Becquerel
City
Rouen Cedex 1
State/Province
Haute-normandie
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
State/Province
Ile-de-france
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
State/Province
Ile-de-france
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
State/Province
Ile-de-france
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille Cedex
State/Province
NORD Pas-de-calais
Country
France
Facility Name
Hôpital Hôtel-Dieu
City
Nantes cedex 1
State/Province
PAYS DE LA Loire
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
State/Province
Provence Alpes COTE D'azur
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
State/Province
Rhone-alpes
Country
France
Facility Name
Universitätsklinik Heidelberg
City
Heidelberg
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Medizinische Klinik der Universität Würzburg
City
Würzburg
State/Province
Bayern
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
Country
Germany
Facility Name
Universitätsklinikum Aachen
City
Aachen
State/Province
Nordrhein-westfalen
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-westfalen
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität
City
Mainz
State/Province
Rheinland-pfalz
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg / Saar
State/Province
Saarland
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
State/Province
Sachsen
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thuringen
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
Country
Germany
Facility Name
Alexandra General Hospital
City
Athens
State/Province
Attica
Country
Greece
Facility Name
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
City
Kecskemét
State/Province
Bacs-kiskun
Country
Hungary
Facility Name
Pécsi Tudományegyetem
City
Pécs
State/Province
Baranya
Country
Hungary
Facility Name
Szegedi Tudományegyetem
City
Szeged
State/Province
Csongrad
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
State/Province
Hajdu-bihar
Country
Hungary
Facility Name
Egyesített Szent István és Szent László Kórház-Rendelointézet
City
Budapest
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mac okato Korhoz
City
Kaposvár
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
Country
Hungary
Facility Name
Rambam Health Corp.
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
The Chaim Sheba Medical Center at Tel Hashomer
City
Tel Hashomer
Country
Israel
Facility Name
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
City
Rionero in Vulture
State/Province
Potenza
Country
Italy
Facility Name
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
City
Orbassano
State/Province
Torino
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera Universitaria San Martino
City
Genova
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Maggiore della Carità
City
Novara
Country
Italy
Facility Name
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
City
Piacenza
Country
Italy
Facility Name
Azienda Ospedaliera Pisana Ospedale Santa Chiara
City
Pisa
Country
Italy
Facility Name
Aienda Policknico Umberto I di Roma
City
Roma
Country
Italy
Facility Name
Azienda Policknico Umberto l di Roma
City
Roma
Country
Italy
Facility Name
Università Tor Vergata Ospedale Sant Eugenio
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
City
Siena
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya City
State/Province
Aichi
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi
State/Province
Aichi
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-city
State/Province
Fukuoka
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki City
State/Province
Gifu
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
National Hospital Organization Nishigunma National Hospital
City
Shibukawa
State/Province
Gunma
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata-city
State/Province
Niigata
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
The Cancer Institute Hospital Of Japanese Foundation For Cancer Research
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Toranornon Hospital
City
Shinagawa
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
City
Kyoto
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
Country
Japan
Facility Name
Tokushima Prefectural Central Hospital
City
Tokushima
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Tokyo
Country
Japan
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Gyeongsangnam-Do
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
North Shore Hospital
City
North Shore City
State/Province
Auckland
Country
New Zealand
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
Country
New Zealand
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Aukland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
City
Torun
State/Province
Kujawsko-Pomorskie
Country
Poland
Facility Name
Zamojski Szpital Niepubliczny Sp. z o.o.
City
Zamosc
State/Province
Lubelskie
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
State/Province
Malopolskie
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
City
Chorzów
State/Province
Slaskie
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
City
Poznan
State/Province
Wielkopolskie
Country
Poland
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
State/Province
Bucuresti
Country
Romania
Facility Name
Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
City
Brasov
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
City
Brasov
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
Country
Romania
Facility Name
Republican Clinical Hospital #1
City
Izhevsk
Country
Russian Federation
Facility Name
City Clinical Hospital n.a. S. P. Botkin
City
Moscow
Country
Russian Federation
Facility Name
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
City
Moscow
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
Country
Russian Federation
Facility Name
Clinical Hospital Number 31
City
Saint Petersburg
Country
Russian Federation
Facility Name
Federal Almazov Medical Research Centre
City
Saint Petersburg
Country
Russian Federation
Facility Name
FGU Russian Scientific Research Institute of Hematology and Transfusiology
City
Saint Petersburg
Country
Russian Federation
Facility Name
First Saint Petersburg I.P. Pavlov State Medical University
City
Saint Petersburg
Country
Russian Federation
Facility Name
GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
City
Samara
Country
Russian Federation
Facility Name
National University Cancer Institute
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Facility Name
Singapore Oncology Consultants
City
Singapore
Country
Singapore
Facility Name
Univerzitná nemocnica Bratislava
City
Bratislava
Country
Slovakia
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Baleares
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Institut Universitari Dexeus
City
Barcelona
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fé de Valencia
City
Valencia
Country
Spain
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-LinKou Branch
City
Tao-Yuan
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
State/Province
Bangkok Metropolis
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
State/Province
Bangkok Metropolis
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
Country
Thailand
Facility Name
City Hematology Center
City
Dnepropetrovsk
State/Province
Dnipropretrovsk
Country
Ukraine
Facility Name
Municipal Institution of Health Protection "Clinical Hospital #8"
City
Kharkov
State/Province
Kharkiv
Country
Ukraine
Facility Name
Cherkassy Regional Oncology Center
City
Cherkassy
Country
Ukraine
Facility Name
MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
City
Donetsk
Country
Ukraine
Facility Name
Khmelnytsky Regional Clinical Hospital
City
Khmelnytsky
Country
Ukraine
Facility Name
Khmelnytsky Regional Hospital, Department of Hematology
City
Khmelnytsky
Country
Ukraine
Facility Name
National Institute of Cancer, Oncohematology Department
City
Kiev
Country
Ukraine
Facility Name
Kyiv Bone Marrow Transplantation Center
City
Kyiv
Country
Ukraine
Facility Name
Lviv Regional Oncology Dispensary
City
Lviv
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
City
Lviv
Country
Ukraine
Facility Name
Regional Clinical Hospital
City
Mykolayiv
Country
Ukraine
Facility Name
Royal Free Hospital
City
London
State/Province
England
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
England
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
England
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
England
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
England
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Surrey
State/Province
England
Country
United Kingdom
Facility Name
Royal Wolverhampton Hospitals Trust
City
Wolverhampton
State/Province
England
Country
United Kingdom

12. IPD Sharing Statement

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Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients

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