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Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma (CLARION)

Primary Purpose

Multiple Myeloma

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

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group [IMWG] diagnostic criteria)
  2. Transplant ineligibility

  3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):

    • Serum M-protein ≥ 0.5 g/dL, or
    • Urine M-protein ≥ 200 mg/24 hours, or
    • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio < 0.26 or > 1.65)
  4. No prior treatment for multiple myeloma
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  1. Multiple myeloma of IgM (immunoglobulin M) subtype
  2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
  3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  4. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
  5. Waldenström macroglobulinemia (WM)
  6. Known amyloidosis

Sites / Locations

  • California Cancer Associates for Research & Excellence, Inc. (cCARE)
  • Marin Cancer Care
  • Sutter Gould Medical Foundation
  • Innovative Clinical Research Institute
  • UF Health Shands Cancer Hospital
  • Evanston KelIogg Cancer Center
  • Billings Clinic Cancer Center
  • Maimonides Cancer Center
  • Weill Cornell Medical Center
  • Gabrail Cancer Center Research
  • Saint Francis Health System
  • Spartanburg Regional Healthcare System
  • Santee Hematology Oncology
  • Seattle Cancer Care Alliance
  • Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)
  • Sanatorio Britanico S.A.
  • Royal Prince Alfred Hospital
  • St. Vincent's Hospital Sydney
  • Central Coast Local Health District
  • Calvary Mater Newcastle
  • Royal Adelaide Hospital
  • Eastern Health - Box Hill Hospital
  • St. Vincent's Hospital Melbourne
  • The Alfred Hospital
  • Border Medical Oncology
  • Royal North Shore Hospital, Haematology Department
  • Medical University of Innsbruck, University Clinic for Internal Medicine V
  • Elisabeth Linz Hospital
  • Vienna Wilhelminen Hospital
  • ZNA, Stuivenberg
  • Saint Joseph Clinic Arlon, Department of Hematology
  • CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)
  • CHU Mont-Godinne
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic
  • Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic
  • Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic
  • Multiprofile Hospital for Active Treatment "Sveta Marina", Varna
  • CSSS-Champlain-Charles LeMoyne
  • Fujian Medical University Union Hospital
  • Guangdong General Hospital
  • Guangzhou First People's Hospital
  • The First Affiliated Hospital of Soochow University
  • The First Hospital of Jilin University
  • The First Affiliated Hospital of the Fourth Military Medical University of PLA
  • The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • 307 Hospital of PLA
  • Beijing Chao Yang Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • Peking University Third Hospital
  • Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Changzheng Hospital
  • Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • University Hospital Brno, Department of Internal Hematology and Oncology
  • University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis
  • University Hospital Hradec Kralove
  • University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology
  • University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO
  • University Hospital Kralovske Vinohrady - Internal Hematology Clinic
  • General University Hospital Prague, 1st Department of Medicine - Department of Hematology
  • CHU de Caen, Côte de Nacre
  • CHU Estaing
  • UHC Dijon, Children's Hospital
  • CHRU Hopital Huriez, Departement of Hematology
  • CHRU Lille Hôpital Claude Huriez
  • Paoli Calmettes Institute, Department ofHematology 2
  • Nantes University Hospital Center
  • Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau
  • Hopital Saini Louis, Service d'immuno-Hematologie
  • Hopital Saint Antoine
  • Hospital Necker
  • South Lyon Hospital Center
  • Centre Hospitalier Lyon Sud, Service d'hématologie Clinique
  • Hopital Pontchaillou
  • Hospital Purpan
  • CHU de Tours Hopital Bretonneau
  • Freiburg University Medical Center
  • Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III
  • Ludwig Maximilians University Hospital - Medical Clinic III
  • University Hospital Cologne
  • Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III
  • Saarland University Hospital
  • Group Practice for Hematology and Oncology
  • Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine
  • Evangelismos Hospital
  • University of Athens, Alexandra Hospital
  • St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant
  • National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology
  • University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology
  • Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology
  • Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology
  • Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine
  • Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
  • Soroka University Medical Center
  • Rambam Medical Center, Department of Hematology
  • Ein Kerem Hospital, Department of Hematology
  • The Chaim Sheba Medical Center
  • UO Clinica Ematologica, IRCCS A.O.U. San Martino
  • A.O.U. San Luigi Gonzaga
  • Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi
  • Maggiore della Carita Hospital of Novara
  • Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema
  • Ospedale S. Eugenio
  • Policlinico Universitario "Umberto I"
  • AO Città della Salute e della Scienza di Torino, Division of Hematology
  • Nagoya City University Hospital
  • Toyohashi Municipal Hospital
  • Kyushu University Hospital
  • National Hospitalization Organization Kyushu Cancer Center
  • Ogaki Municipal Hospital
  • Gunma University Hospital
  • Sapporo Medical University Hospital
  • National Hospital Organization Okayama Medical Center
  • Osaka University Hospital
  • Japanese Red Cross Medical Center
  • Tochigi Cancer Center
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • National Center for Global Health and Medicine
  • National Hospital Organization Disaster Medical Center
  • University Hospital, Kyoto Prefectural University of Medicine
  • Tokushima Prefectural Central Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Chonnam National University Hwasun Hospital
  • Pusan National University Hospital
  • Inje University Busan Paik Hospital
  • Kyungpook National University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Asan Medical Center
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Fundacion Centro Oncologieo de Integracion Regional - COIR
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles
  • Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology
  • St. Antonius Ziekenhuis, Department of Hematology
  • Erasmus Medical Center
  • Isala Clinics in Zwolle, Department of Oncology
  • North Shore Hospital
  • Auckland City Hospital
  • Canterbury Health Laboratories
  • Wellington Hospital
  • Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn
  • Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology
  • Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
  • Independent Public Healthcare Facility University Hospital
  • Nicolaus Copernicus Memorial Provincial Specialist Hospital
  • Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology
  • Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology
  • Maria Sklodowska-Curie Institute of Oncology
  • "Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department
  • Iasi Regional Institute for Oncology, Medical Hematology Department
  • Brasov County Emergency Clinical Hospital, Hematology Department
  • Fundeni Clinical Institute, Hematology Department
  • Coltea Clinical Hospital, Hematology Department
  • Bucharest Emergency University Hospital, Hematology Department
  • Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation
  • State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology
  • Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2
  • State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
  • Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences
  • City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
  • State Higher Educational Institution St. Petersburg Pavlov State Medical University
  • The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian
  • Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care
  • City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
  • National University Hospital
  • Singapore General Hospital
  • Singapore Oncology Consultants, Gleneagles Hospital
  • OncoCare Cancer Center
  • Singapore General Hospital
  • Hospital Universitari Germans Trias i Pujol
  • University Hospital of Navarra
  • Hospital Clinic i Provincial Barcelona
  • Hospital Universitario 12 De Octubre
  • Hospital Universitario, Salamanca
  • Hospital Virgen del Rocio University
  • Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología
  • Hospital Quiron Zaragoza
  • University Hospital Center Vaudois
  • County Hospital Saint Gallen
  • Changhua Christian Hospital
  • Kuohsiung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang-Gung Memorial Hospital, Linkou
  • Ege University Medical Faculty
  • Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department
  • Marmara University Pendik Training and Research Hospital
  • Cherkasy Regional Oncology Center
  • Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre
  • Kharkiv Regional Clinical Oncology Center, Department of Hematology
  • Khmelnytskyi Regional Hospital, Hematology Department
  • Kyiv Center for Bone Marrow Transplantation
  • Institute of Blood Pathology and Transfusion Medicine
  • Poltava M.V. Sklifosovskyi Regional Clinical-Hospital
  • A. Novak Zakarpattia Regional Clinical Hospital
  • M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department
  • O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center
  • Kent and Canterbury Hospital
  • Maidstone Hospital, Kent Oncology Centre
  • Northwick Park Hospital
  • Raigmore Hospital
  • University College London, Cancer Centre
  • Guy's and St. Thomas' NHS Foundation Trust
  • Oxford University Hospitals NHS Trust, Churchill Hospital
  • The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carfilzomib, Melphalan, Prednisone

Bortezomib, Melphalan, Prednisone

Arm Description

Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression. Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.

Secondary Outcome Measures

Overall Survival (OS)
Overall survival (OS) was 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 on the date the patient was last known to be alive. Median overall survival was estimated using the Kaplan-Meier method.
Overall Response Rate
Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). 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.
Complete Response Rate
Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response. 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.
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.
European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL.
Number of Participants With Adverse Events
Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal. A serious adverse event is an adverse event that met 1 or more of the following criteria: Death Life-threatening Required inpatient hospitalization or prolongation of an existing hospitalization Resulted in persistent or significant disability/incapacity Congenital anomaly/birth defect Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above. Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.

Full Information

First Posted
February 12, 2013
Last Updated
August 9, 2019
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01818752
Brief Title
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
Acronym
CLARION
Official Title
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 8, 2013 (Actual)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
November 4, 2016 (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 was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Carfilzomib, Melphalan, Prednisone
Arm Type
Experimental
Arm Description
Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Arm Title
Bortezomib, Melphalan, Prednisone
Arm Type
Active Comparator
Arm Description
Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
Krypolis®
Intervention Description
Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade®
Intervention Description
Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression. Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.
Time Frame
From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) was 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 on the date the patient was 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 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.
Title
Overall Response Rate
Description
Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). 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 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
Title
Complete Response Rate
Description
Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response. 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.
Time Frame
Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms 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 any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
Title
European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
Description
The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL.
Time Frame
Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
Title
Number of Participants With Adverse Events
Description
Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal. A serious adverse event is an adverse event that met 1 or more of the following criteria: Death Life-threatening Required inpatient hospitalization or prolongation of an existing hospitalization Resulted in persistent or significant disability/incapacity Congenital anomaly/birth defect Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above. Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.
Time Frame
From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group [IMWG] diagnostic criteria) Transplant ineligibility Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization): Serum M-protein ≥ 0.5 g/dL, or Urine M-protein ≥ 200 mg/24 hours, or In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio < 0.26 or > 1.65) No prior treatment for multiple myeloma Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: Multiple myeloma of IgM (immunoglobulin M) subtype Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential) Waldenström macroglobulinemia (WM) Known amyloidosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Associates for Research & Excellence, Inc. (cCARE)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Sutter Gould Medical Foundation
City
Modesto
State/Province
California
ZIP/Postal Code
95357
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Evanston KelIogg Cancer Center
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Maimonides Cancer Center
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Saint Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Spartanburg Regional Healthcare System
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Santee Hematology Oncology
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Britanico S.A.
City
Santa Fe
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Central Coast Local Health District
City
North Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Eastern Health - Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Royal North Shore Hospital, Haematology Department
City
New South Wales
Country
Australia
Facility Name
Medical University of Innsbruck, University Clinic for Internal Medicine V
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Elisabeth Linz Hospital
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Vienna Wilhelminen Hospital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
ZNA, Stuivenberg
City
Antwerp
State/Province
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Saint Joseph Clinic Arlon, Department of Hematology
City
Arlon
State/Province
Luxembourg
ZIP/Postal Code
6700
Country
Belgium
Facility Name
CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveta Marina", Varna
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
CSSS-Champlain-Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
State/Province
Fujian
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Affiliated Hospital of the Fourth Military Medical University of PLA
City
Xi'an City
State/Province
Shanxi
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
307 Hospital of PLA
City
Beijing
Country
China
Facility Name
Beijing Chao Yang Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Facility Name
Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University
City
Tianjin
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Facility Name
University Hospital Brno, Department of Internal Hematology and Oncology
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
University Hospital Kralovske Vinohrady - Internal Hematology Clinic
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
General University Hospital Prague, 1st Department of Medicine - Department of Hematology
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU de Caen, Côte de Nacre
City
Caen Cedex 9
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
UHC Dijon, Children's Hospital
City
Dijon
Country
France
Facility Name
CHRU Hopital Huriez, Departement of Hematology
City
Lille Cedex
Country
France
Facility Name
CHRU Lille Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Paoli Calmettes Institute, Department ofHematology 2
City
Marseille cedex
Country
France
Facility Name
Nantes University Hospital Center
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau
City
Nimes cedex 9
Country
France
Facility Name
Hopital Saini Louis, Service d'immuno-Hematologie
City
Paris
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
Country
France
Facility Name
Hospital Necker
City
Paris
Country
France
Facility Name
South Lyon Hospital Center
City
Pierre Bénite, cedex
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Hospitalier Lyon Sud, Service d'hématologie Clinique
City
Pierre Bénite, Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes Cedex 9
Country
France
Facility Name
Hospital Purpan
City
Toulouse Cedex 9
Country
France
Facility Name
CHU de Tours Hopital Bretonneau
City
Tours Cedex 1
Country
France
Facility Name
Freiburg University Medical Center
City
Freiburg
State/Province
Baden-Wuerttemberg
Country
Germany
Facility Name
Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III
City
Ulm
State/Province
Baden-Wuerttemberg
Country
Germany
Facility Name
Ludwig Maximilians University Hospital - Medical Clinic III
City
Munich
State/Province
Bavaria
Country
Germany
Facility Name
University Hospital Cologne
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III
City
Mainz
State/Province
Rhineland-Palatinate
Country
Germany
Facility Name
Saarland University Hospital
City
Homburg / Saar
State/Province
Saarland
Country
Germany
Facility Name
Group Practice for Hematology and Oncology
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Evangelismos Hospital
City
Athens
State/Province
Attica
ZIP/Postal Code
10676
Country
Greece
Facility Name
University of Athens, Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
P.O.B 151
Country
Israel
Facility Name
Rambam Medical Center, Department of Hematology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Ein Kerem Hospital, Department of Hematology
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
UO Clinica Ematologica, IRCCS A.O.U. San Martino
City
Genova
State/Province
GE
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga
City
Orbassano
State/Province
TO
Country
Italy
Facility Name
Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi
City
Ancona
Country
Italy
Facility Name
Maggiore della Carita Hospital of Novara
City
Novara
Country
Italy
Facility Name
Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema
City
Piacenza
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
Country
Italy
Facility Name
Policlinico Universitario "Umberto I"
City
Rome
Country
Italy
Facility Name
AO Città della Salute e della Scienza di Torino, Division of Hematology
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi
State/Province
Aichi
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
State/Province
Fukuoka-Ken
Country
Japan
Facility Name
National Hospitalization Organization Kyushu Cancer Center
City
Minami-ku
State/Province
Fukuoka
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
State/Province
Gifu
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo-shi
State/Province
Hokkaidou
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama-city
State/Province
Okayama
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Tokyo
State/Province
Shibuya-ku
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Koto
State/Province
Tokyo
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tachikawa-city
State/Province
Tokyo
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
Country
Japan
Facility Name
Tokushima Prefectural Central Hospital
City
Tokushima
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
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
110-774
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Fundacion Centro Oncologieo de Integracion Regional - COIR
City
Mendoza
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
Country
Mexico
Facility Name
Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles
City
Puebla
Country
Mexico
Facility Name
Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology
City
Amsterdam
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis, Department of Hematology
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Isala Clinics in Zwolle, Department of Oncology
City
Zwolle
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Canterbury Health Laboratories
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn
City
Olsztyn
State/Province
OIsztyn
Country
Poland
Facility Name
Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology
City
Chorzow
State/Province
Slaskie
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
City
Katowice
ZIP/Postal Code
40-032
Country
Poland
Facility Name
Independent Public Healthcare Facility University Hospital
City
Krakow
Country
Poland
Facility Name
Nicolaus Copernicus Memorial Provincial Specialist Hospital
City
Lodz
Country
Poland
Facility Name
Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology
City
Lublin
Country
Poland
Facility Name
Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Maria Sklodowska-Curie Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
"Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department
City
Cluj-Napoca
State/Province
Cluj County
ZIP/Postal Code
400124
Country
Romania
Facility Name
Iasi Regional Institute for Oncology, Medical Hematology Department
City
Iasi
State/Province
Iasi County
ZIP/Postal Code
700483
Country
Romania
Facility Name
Brasov County Emergency Clinical Hospital, Hematology Department
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Fundeni Clinical Institute, Hematology Department
City
Bucharest
ZIP/Postal Code
022 328
Country
Romania
Facility Name
Coltea Clinical Hospital, Hematology Department
City
Bucharest
ZIP/Postal Code
030 171
Country
Romania
Facility Name
Bucharest Emergency University Hospital, Hematology Department
City
Bucharest
ZIP/Postal Code
50098
Country
Romania
Facility Name
Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation
City
Targu-Mures
ZIP/Postal Code
540042
Country
Romania
Facility Name
State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology
City
Petrozavodsk
State/Province
Republic Of Karelia
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2
City
Arkhangelsk
Country
Russian Federation
Facility Name
State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
City
Izhevsk
ZIP/Postal Code
426039
Country
Russian Federation
Facility Name
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
State Higher Educational Institution St. Petersburg Pavlov State Medical University
City
Saint Petersburg
Country
Russian Federation
Facility Name
The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian
City
Saint Petersburg
Country
Russian Federation
Facility Name
Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Singapore Oncology Consultants, Gleneagles Hospital
City
Singapore
ZIP/Postal Code
258500
Country
Singapore
Facility Name
OncoCare Cancer Center
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barselona
ZIP/Postal Code
8916
Country
Spain
Facility Name
University Hospital of Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital Clinic i Provincial Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario, Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Virgen del Rocio University
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Quiron Zaragoza
City
Zaragoza
Country
Spain
Facility Name
University Hospital Center Vaudois
City
Lausanne
Country
Switzerland
Facility Name
County Hospital Saint Gallen
City
Saint Gallen
Country
Switzerland
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Kuohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linkou
City
Tapei
Country
Taiwan
Facility Name
Ege University Medical Faculty
City
Izmir
State/Province
Bornova
Country
Turkey
Facility Name
Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department
City
Ankara
State/Province
Cebeci
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
State/Province
Pendik
Country
Turkey
Facility Name
Cherkasy Regional Oncology Center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Oncology Center, Department of Hematology
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Khmelnytskyi Regional Hospital, Hematology Department
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Kyiv Center for Bone Marrow Transplantation
City
Kyiv
ZIP/Postal Code
03 115
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Poltava M.V. Sklifosovskyi Regional Clinical-Hospital
City
Poltava
Country
Ukraine
Facility Name
A. Novak Zakarpattia Regional Clinical Hospital
City
Uzhgorod
Country
Ukraine
Facility Name
M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department
City
Vinnitsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CTI 3NG
Country
United Kingdom
Facility Name
Maidstone Hospital, Kent Oncology Centre
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
Middlesex
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
University College London, Cancer Centre
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust, Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29991494
Citation
Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.
Results Reference
background
PubMed Identifier
30819926
Citation
Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.
Results Reference
background
PubMed Identifier
26771810
Citation
Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

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