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

August 9, 2019 updated by: Amgen

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
955

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)
      • Santa Fe, Argentina
        • Sanatorio Britanico S.A.
  • Australia
      • New South Wales, Australia
        • Royal North Shore Hospital, Haematology Department
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
      • North Gosford, New South Wales, Australia, 2250
        • Central Coast Local Health District
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health - Box Hill Hospital
      • Fitzroy, Victoria, Australia
        • St. Vincent's Hospital Melbourne
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
  • Austria
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck, University Clinic for Internal Medicine V
      • Linz, Austria, 4020
        • Elisabeth Linz Hospital
      • Vienna, Austria, 1160
        • Vienna Wilhelminen Hospital
  • Belgium
      • Liège, Belgium, 4000
        • CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)
      • Yvoir, Belgium, 5530
        • CHU Mont-Godinne
    • Antwerpen
      • Antwerp, Antwerpen, Belgium, 2060
        • ZNA, Stuivenberg
    • Luxembourg
      • Arlon, Luxembourg, Belgium, 6700
        • Saint Joseph Clinic Arlon, Department of Hematology
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic
      • Sofia, Bulgaria, 1606
        • Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic
      • Sofia, Bulgaria, 1756
        • Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic
      • Varna, Bulgaria, 9010
        • Multiprofile Hospital for Active Treatment "Sveta Marina", Varna
  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
        • CSSS-Champlain-Charles LeMoyne
  • China
      • Beijing, China
        • Peking University Third Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China
        • 307 Hospital of PLA
      • Beijing, China
        • Beijing Chao Yang Hospital, Capital Medical University
      • Shanghai, China
        • Shanghai Changzheng Hospital
      • Shanghai, China
        • Rui Jin hospital, Shanghai Jiao Tong university school of medicine
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, China
        • Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University
    • Fujian
      • Fuzhou City, Fujian, China
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China
        • Guangzhou First People's Hospital
    • Jiangsu
      • Suzhou, Jiangsu, China
        • The First Affiliated Hospital of Soochow University
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
    • Shanxi
      • Xi'an City, Shanxi, China
        • The First Affiliated Hospital of the Fourth Military Medical University of PLA
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin
  • Czechia
      • Brno, Czechia, 625 00
        • University Hospital Brno, Department of Internal Hematology and Oncology
      • Brno, Czechia, 625 00
        • University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis
      • Hradec Kralove, Czechia, 500 05
        • University Hospital Hradec Kralove
      • Olomouc, Czechia, 775 20
        • University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology
      • Ostrava, Czechia, 708 52
        • University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO
      • Prague, Czechia, 10034
        • University Hospital Kralovske Vinohrady - Internal Hematology Clinic
      • Prague, Czechia, 128 08
        • General University Hospital Prague, 1st Department of Medicine - Department of Hematology
  • France
      • Caen Cedex 9, France, 14033
        • CHU de Caen, Côte de Nacre
      • Clermont-Ferrand, France, 63000
        • Chu Estaing
      • Dijon, France
        • UHC Dijon, Children's Hospital
      • Lille, France, 59037
        • CHRU Lille Hôpital Claude Huriez
      • Lille Cedex, France
        • CHRU Hopital Huriez, Departement of Hematology
      • Marseille cedex, France
        • Paoli Calmettes Institute, Department ofHematology 2
      • Nantes Cedex 1, France, 44093
        • Nantes University Hospital Center
      • Nimes cedex 9, France
        • Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hopital Saini Louis, Service d'immuno-Hematologie
      • Paris, France
        • Hospital Necker
      • Pierre Bénite, Cedex, France, 69495
        • Centre Hospitalier Lyon Sud, Service d'hématologie Clinique
      • Pierre Bénite, cedex, France, 69310
        • South Lyon Hospital Center
      • Rennes Cedex 9, France
        • Hôpital Pontchaillou
      • Toulouse Cedex 9, France
        • Hospital Purpan
      • Tours Cedex 1, France
        • CHU de Tours Hopital Bretonneau
  • Germany
      • Dresden, Germany, 1307
        • Group Practice for Hematology and Oncology
      • Koblenz, Germany, 56068
        • Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany
        • Freiburg University Medical Center
      • Ulm, Baden-Wuerttemberg, Germany
        • Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III
    • Bavaria
      • Munich, Bavaria, Germany
        • Ludwig Maximilians University Hospital - Medical Clinic III
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 50937
        • University Hospital Cologne
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany
        • Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III
    • Saarland
      • Homburg / Saar, Saarland, Germany
        • Saarland University Hospital
  • Greece
      • Athens, Greece, 11528
        • University of Athens, Alexandra Hospital
    • Attica
      • Athens, Attica, Greece, 10676
        • Evangelismos Hospital
  • Hungary
      • Budapest, Hungary, 1097
        • St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant
      • Budapest, Hungary, 1122
        • National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology
      • Debrecen, Hungary, 4032
        • University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology
      • Gyula, Hungary, 5700
        • Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology
      • Kaposvar, Hungary, 7400
        • Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine
      • Pecs, Hungary, 7624
        • Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
  • Israel
      • Beer-Sheva, Israel, P.O.B 151
        • Soroka university medical center
      • Haifa, Israel, 31096
        • Rambam Medical Center, Department of Hematology
      • Jerusalem, Israel, 91120
        • Ein Kerem Hospital, Department of Hematology
      • Tel Hashomer, Israel
        • The Chaim Sheba Medical Center
  • Italy
      • Ancona, Italy
        • Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi
      • Novara, Italy
        • Maggiore della Carita Hospital of Novara
      • Piacenza, Italy
        • Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema
      • Roma, Italy
        • Ospedale S. Eugenio
      • Rome, Italy
        • Policlinico Universitario "Umberto I"
      • Torino, Italy, 10126
        • AO Città della Salute e della Scienza di Torino, Division of Hematology
    • GE
      • Genova, GE, Italy
        • UO Clinica Ematologica, IRCCS A.O.U. San Martino
    • TO
      • Orbassano, TO, Italy
        • A.O.U. San Luigi Gonzaga
  • Japan
      • Kyoto, Japan
        • University Hospital, Kyoto Prefectural University of Medicine
      • Tokushima, Japan
        • Tokushima Prefectural Central Hospital
    • Aichi
      • Nagoya, Aichi, Japan
        • Nagoya City University Hospital
      • Toyohashi, Aichi, Japan
        • Toyohashi Municipal Hospital
    • Fukuoka
      • Minami-ku, Fukuoka, Japan
        • National Hospitalization Organization Kyushu Cancer Center
    • Fukuoka-Ken
      • Fukuoka, Fukuoka-Ken, Japan
        • Kyushu University Hospital
    • Gifu
      • Ogaki, Gifu, Japan
        • Ogaki Municipal Hospital
    • Gunma
      • Maebashi, Gunma, Japan
        • Gunma University Hospital
    • Hokkaidou
      • Sapporo-shi, Hokkaidou, Japan
        • Sapporo Medical University Hospital
    • Okayama
      • Okayama-city, Okayama, Japan
        • National Hospital Organization Okayama Medical Center
    • Osaka
      • Suita, Osaka, Japan
        • Osaka University Hospital
    • Shibuya-ku
      • Tokyo, Shibuya-ku, Japan
        • Japanese Red Cross Medical Center
    • Tochigi
      • Utsunomiya, Tochigi, Japan
        • Tochigi Cancer Center
    • Tokyo
      • Koto, Tokyo, Japan
        • The Cancer institute Hospital of Japanese Foundation for Cancer Research
      • Shinjuku, Tokyo, Japan
        • National Center for Global Health and Medicine
      • Tachikawa-city, Tokyo, Japan
        • National Hospital Organization Disaster Medical Center
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 614-735
        • Inje University Busan Paik Hospital
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 110-774
        • Seoul National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Jeollanam-do
      • Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
  • Mexico
      • Mendoza, Mexico
        • Fundacion Centro Oncologieo de Integracion Regional - COIR
      • Mexico City, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Puebla, Mexico
        • Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Netherlands
      • Amsterdam, Netherlands
        • Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis, Department of Hematology
      • Rotterdam, Netherlands
        • Erasmus Medical Center
      • Zwolle, Netherlands
        • Isala Clinics in Zwolle, Department of Oncology
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Auckland, New Zealand, 0622
        • North Shore Hospital
      • Christchurch, New Zealand, 8011
        • Canterbury Health Laboratories
      • Wellington, New Zealand, 6021
        • Wellington Hospital
  • Poland
      • Katowice, Poland, 40-032
        • Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
      • Krakow, Poland
        • Independent Public Healthcare Facility University Hospital
      • Lodz, Poland
        • Nicolaus Copernicus Memorial Provincial Specialist Hospital
      • Lublin, Poland
        • Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology
      • Torun, Poland, 87-100
        • Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Institute of Oncology
    • OIsztyn
      • Olsztyn, OIsztyn, Poland
        • Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn
    • Slaskie
      • Chorzow, Slaskie, Poland, 41-500
        • Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology
  • Romania
      • Brasov, Romania, 500326
        • Brasov County Emergency Clinical Hospital, Hematology Department
      • Bucharest, Romania, 022 328
        • Fundeni Clinical Institute, Hematology Department
      • Bucharest, Romania, 030 171
        • Coltea Clinical Hospital, Hematology Department
      • Bucharest, Romania, 50098
        • Bucharest Emergency University Hospital, Hematology Department
      • Targu-Mures, Romania, 540042
        • Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation
    • Cluj County
      • Cluj-Napoca, Cluj County, Romania, 400124
        • "Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department
    • Iasi County
      • Iasi, Iasi County, Romania, 700483
        • Iasi Regional Institute for Oncology, Medical Hematology Department
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2
      • Izhevsk, Russian Federation, 426039
        • State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
      • Moscow, Russian Federation, 115478
        • Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences
      • Moscow, Russian Federation, 125284
        • City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
      • Saint Petersburg, Russian Federation
        • State Higher Educational Institution St. Petersburg Pavlov State Medical University
      • Saint Petersburg, Russian Federation
        • The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian
      • St. Petersburg, Russian Federation, 191024
        • Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
    • Republic Of Karelia
      • Petrozavodsk, Republic Of Karelia, Russian Federation, 185019
        • State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore, 119228
        • National University Hospital
      • Singapore, Singapore, 258500
        • Singapore Oncology Consultants, Gleneagles Hospital
      • Singapore, Singapore
        • Oncocare Cancer Center
  • Spain
      • Barcelona, Spain
        • Hospital Clinic i Provincial Barcelona
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Salamanca, Spain, 37007
        • Hospital Universitario, Salamanca
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocio University
      • Valencia, Spain, 46026
        • Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología
      • Zaragoza, Spain
        • Hospital Quirón Zaragoza
    • Barselona
      • Badalona, Barselona, Spain, 8916
        • Hospital Universitari Germans Trias i Pujol
    • Navarra
      • Pamplona, Navarra, Spain
        • University Hospital of Navarra
  • Switzerland
      • Lausanne, Switzerland
        • University Hospital Center Vaudois
      • Saint Gallen, Switzerland
        • County Hospital Saint Gallen
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan
        • Kuohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Tapei, Taiwan
        • Chang-Gung Memorial Hospital, Linkou
  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey
        • Ege University Medical Faculty
    • Cebeci
      • Ankara, Cebeci, Turkey, 06590
        • Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department
    • Pendik
      • Istanbul, Pendik, Turkey
        • Marmara University Pendik Training and Research Hospital
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Cherkasy Regional Oncology Center
      • Dnipropetrovsk, Ukraine, 49102
        • Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre
      • Kharkiv, Ukraine, 61070
        • Kharkiv Regional Clinical Oncology Center, Department of Hematology
      • Khmelnytskyi, Ukraine, 29000
        • Khmelnytskyi Regional Hospital, Hematology Department
      • Kyiv, Ukraine, 03 115
        • Kyiv Center for Bone Marrow Transplantation
      • Lviv, Ukraine, 79044
        • Institute of Blood Pathology and Transfusion Medicine
      • Poltava, Ukraine
        • Poltava M.V. Sklifosovskyi Regional Clinical-Hospital
      • Uzhgorod, Ukraine
        • A. Novak Zakarpattia Regional Clinical Hospital
      • Vinnitsya, Ukraine, 21018
        • M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department
      • Zhytomyr, Ukraine, 10002
        • O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center
  • United Kingdom
      • Inverness, United Kingdom, IV2 3UJ
        • Raigmore Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' NHS Foundation Trust
      • London, United Kingdom, NW1 2PG
        • University College London, Cancer Centre
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Trust, Churchill Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital
    • Kent
      • Canterbury, Kent, United Kingdom, CTI 3NG
        • Kent and Canterbury Hospital
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Maidstone Hospital, Kent Oncology Centre
    • Middlesex
      • Harrow, Middlesex, United Kingdom
        • Northwick Park Hospital
  • United States
    • California
      • Fresno, California, United States, 93720
        • California Cancer Associates for Research & Excellence, Inc. (cCARE)
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care
      • Modesto, California, United States, 95357
        • Sutter Gould Medical Foundation
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Gainesville, Florida, United States
        • UF Health Shands Cancer Hospital
    • Illinois
      • Evanston, Illinois, United States
        • Evanston KelIogg Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • New York
      • Brooklyn, New York, United States
        • Maimonides Cancer Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Health System
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Healthcare System
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology Oncology
    • Washington
      • Seattle, Washington, United States
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Carfilzomib, Melphalan, Prednisone
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.
Drug: Carfilzomib
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.
Other Names:
  • Krypolis®
Drug: Melphalan
Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
Drug: Prednisone
Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
Active Comparator: Bortezomib, Melphalan, Prednisone
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.
Drug: Melphalan
Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
Drug: Prednisone
Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
Drug: Bortezomib
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.
Other Names:
  • Velcade®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
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.

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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
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.

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.
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.
Overall Response Rate
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.

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.
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.
Complete Response Rate
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.

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.
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.
Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
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.

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.
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.
European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
Time Frame: Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48

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.
Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
Number of Participants With Adverse Events
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.

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-005
  • 2012-005283-97 (EudraCT Number)
  • 20130397 (Other Identifier: Amgen Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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