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

November 10, 2022 updated by: Amgen

A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

929

Phase

  • 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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia
        • St. Vincent's Public Hospital Sydney
      • Kogarah, New South Wales, Australia
        • Saint George Hospital
      • Liverpool, New South Wales, Australia
        • Liverpool Hospital
      • Saint Leonards, New South Wales, Australia
        • Royal North Shore Hospital
      • Waratah, New South Wales, Australia
        • Calvary Mater Newcastle
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia
        • Royal Brisbane and Women's Hospital
      • South Brisbane, Queensland, Australia
        • Haematology & Oncology Clinics of Australia
      • South Brisbane, Queensland, Australia
        • Haematology and Oncology Clinics of Australia at Chermside
      • South Brisbane, Queensland, Australia
        • Haematology and Oncology Clinics of Australia at Wesley
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
      • Woodville, South Australia, Australia
        • The Queen Elizabeth Hospital
    • Victoria
      • Box Hill, Victoria, Australia
        • Box Hill Hospital
      • Clayton, Victoria, Australia
        • Monash Medical Centre
      • East Melbourne, Victoria, Australia
        • Saint Vincent's Hospital
      • Footscray, Victoria, Australia
        • Western Hospital
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
      • St. Albans, Victoria, Australia
        • Sunshine Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Fremantle Hospital
      • Perth, Western Australia, Australia
        • Royal Perth Hospital
  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria
        • Medizinische Universität Innsbruck
    • Upper Austria
      • Linz, Upper Austria, Austria
        • Krankenhaus der Elisabethinen Linz, I Interne Abteilung
    • Vienna
      • Wien, Vienna, Austria
        • Wilhelminenspital der Stadt Wien
  • Belgium
      • Antwerp, Belgium
        • Ziekenhuis Netwerk Antwerpen
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
      • Brussels, Belgium
        • Cliniques Universitaires Saint Luc
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium
        • Universitair Ziekenhuis Leuven
    • Namur
      • Yvoir, Namur, Belgium
        • Cliniques Universitaires UCL de Mont-Godinne
    • Oost-vlaanderen
      • Ghent, Oost-vlaanderen, Belgium
        • Universitair Ziekenhuis Gent
  • Brazil
      • Rio de Janeiro, Brazil
        • Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
      • Rio de Janeiro, Brazil
        • Instituto Centros Oncológicos Integrados de Educação e Pesquisa
      • Rio de Janeiro, Brazil
        • Instituto Nacional do Câncer-INCA
      • São Paulo, Brazil
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
    • RIO Grande DO Norte
      • Natal, RIO Grande DO Norte, Brazil
        • Liga Norte Riograndense contra o cancer
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil
        • Clínica de Oncologia de Porto Alegre
      • Porto Alegre, RIO Grande DO SUL, Brazil
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, RIO Grande DO SUL, Brazil
        • Hospital Sao Lucas da PUCRS
    • SAO Paulo
      • Campinas, SAO Paulo, Brazil
        • Hemocentro Campinas-Unicamp
  • Bulgaria
      • Plovdiv, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
      • Varna, Bulgaria
        • Multiprofile Hospital for Active Treatment, "Sveta Marina''
    • Sofiya
      • Sofia, Sofiya, Bulgaria
        • Military Medical Academy Hospital for Active Treatment
      • Sofia, Sofiya, Bulgaria
        • Shato, Ead
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Kelowna, British Columbia, Canada
        • British Columbia Cancer Agency
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Saint John Regional Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II Health Science Centre
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital Regional Cancer Centre
      • Windsor, Ontario, Canada
        • Windsor Regional Hospital
    • Quebec
      • Montréal, Quebec, Canada
        • Hôpital Maisonneuve-Rosemont
  • Czechia
      • Brno, Czechia
        • Fakultní nemocnice Brno
      • Praha, Czechia
        • Vseobecna fakultni nemocnice v Praze
    • Praha
      • Praha 10, Praha, Czechia
        • Fakultni nemocnice Kralovske Vinohrady
    • Severomoravsky KRAJ
      • Olomouc, Severomoravsky KRAJ, Czechia
        • Fakultni nemocnice Olomouc
      • Ostrava, Severomoravsky KRAJ, Czechia
        • FN Ostrava
    • Vychodocesky KRAJ
      • Hradec Kralové, Vychodocesky KRAJ, Czechia
        • Fakultni nemocnice Hradec Kralove
  • France
    • Aquitaine
      • Bayonne, Aquitaine, France
        • Centre Hospitalier de la Cote Basque
    • Bretagne
      • Brest Cedex, Bretagne, France
        • Centre Hospitalier Universitaire Brest
      • Rennes Cedex 9, Bretagne, France
        • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
    • Cedex 1
      • Nantes, Cedex 1, France
        • Hopital Hotel-Dieu - Service d'Hematologie
    • Haute-normandie
      • Rouen Cedex 1, Haute-normandie, France
        • Centre Henri-Becquerel
    • Ile-de-france
      • Le Chesnay, Ile-de-france, France
        • Centre Hospitalier De Versailles
      • Paris, Ile-de-france, France
        • Hôpital Saint Louis
      • Paris, Ile-de-france, France
        • Hôpital Saint-Antoine
    • NORD Pas-de-calais
      • Lille Cedex, NORD Pas-de-calais, France
        • Hôpital Claude Huriez
    • PAYS DE LA Loire
      • Nantes cedex 1, PAYS DE LA Loire, France
        • Hôpital Hôtel-Dieu
    • Provence Alpes COTE D'azur
      • Marseille Cedex 9, Provence Alpes COTE D'azur, France
        • Institut Paoli Calmettes
    • Rhone-alpes
      • Pierre Bénite Cedex, Rhone-alpes, France
        • Centre Hospitalier Lyon Sud
  • Germany
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Hamburg, Germany
        • Universitatsklinikum Hamburg Eppendorf
    • Baden-wuerttemberg
      • Heidelberg, Baden-wuerttemberg, Germany
        • Universitätsklinik Heidelberg
      • Tübingen, Baden-wuerttemberg, Germany
        • Universitätsklinikum Tübingen
      • Ulm, Baden-wuerttemberg, Germany
        • Universitätsklinikum Ulm
    • Bayern
      • Würzburg, Bayern, Germany
        • Medizinische Klinik der Universität Würzburg
    • Niedersachsen
      • Hannover, Niedersachsen, Germany
        • Medizinische Hochschule Hannover
    • Nordrhein-westfalen
      • Aachen, Nordrhein-westfalen, Germany
        • Universitätsklinikum Aachen
      • Münster, Nordrhein-westfalen, Germany
        • Universitätsklinikum Münster
    • Rheinland-pfalz
      • Mainz, Rheinland-pfalz, Germany
        • Universitätsmedizin der Johannes Gutenberg Universität
    • Saarland
      • Homburg / Saar, Saarland, Germany
        • Universitätsklinikum des Saarlandes
    • Sachsen
      • Chemnitz, Sachsen, Germany
        • Klinikum Chemnitz gGmbH
      • Dresden, Sachsen, Germany
        • Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
      • Leipzig, Sachsen, Germany
        • Universitatsklinikum Leipzig
    • Thuringen
      • Jena, Thuringen, Germany
        • Universitatsklinikum Jena
  • Greece
    • Attica
      • Athens, Attica, Greece
        • Alexandra General Hospital
  • Hungary
      • Budapest, Hungary
        • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
      • Kaposvár, Hungary
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Kaposvár, Hungary
        • Somogy Megyei Kaposi Mac okato Korhoz
    • Bacs-kiskun
      • Kecskemét, Bacs-kiskun, Hungary
        • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
    • Baranya
      • Pécs, Baranya, Hungary
        • Pécsi Tudományegyetem
    • Csongrad
      • Szeged, Csongrad, Hungary
        • Szegedi Tudomanyegyetem
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary
        • Debreceni Egyetem Klinikai Kozpont
  • Israel
      • Haifa, Israel
        • Rambam Health Corp.
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Tel Hashomer, Israel
        • The Chaim Sheba Medical Center at Tel HaShomer
  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Brescia, Italy
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Genova, Italy
        • Irccs Azienda Ospedaliera Universitaria San Martino
      • Novara, Italy
        • Azienda Ospedaliera Universitaria Maggiore della Carità
      • Piacenza, Italy
        • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
      • Pisa, Italy
        • Azienda Ospedaliera Pisana Ospedale Santa Chiara
      • Roma, Italy
        • Aienda Policknico Umberto I di Roma
      • Roma, Italy
        • Azienda Policknico Umberto l di Roma
      • Roma, Italy
        • Università Tor Vergata Ospedale Sant Eugenio
      • Siena, Italy
        • Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
      • Torino, Italy
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Potenza
      • Rionero in Vulture, Potenza, Italy
        • IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
    • Torino
      • Orbassano, Torino, Italy
        • Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
  • Japan
      • Fukuoka, Japan
        • Kyushu University Hospital
      • Kyoto, Japan
        • University Hospital, Kyoto Prefectural University of Medicine
      • Kyoto, Japan
        • Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
      • Okayama, Japan
        • National Hospital Organization Okayama Medical Center
      • Tokushima, Japan
        • Tokushima Prefectural Central Hospital
      • Tokyo, Japan
        • Japanese Red Cross Medical Center
    • Aichi
      • Nagoya City, Aichi, Japan
        • Nagoya City University Hospital
      • Toyohashi, Aichi, Japan
        • Toyohashi Municipal Hospital
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan
        • National Hospital Organization Kyushu Cancer Center
    • Gifu
      • Ogaki City, Gifu, Japan
        • Ogaki Municipal Hospital
    • Gunma
      • Maebashi, Gunma, Japan
        • Gunma University Hospital
      • Shibukawa, Gunma, Japan
        • National Hospital Organization Nishigunma National Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Sapporo Medical University Hospital
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City Medical Center General Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Tokai University Hospital
    • Niigata
      • Niigata-city, Niigata, Japan
        • Niigata Cancer Center Hospital
    • Osaka
      • Suita, Osaka, Japan
        • Osaka University Hospital
    • Saitama
      • Kawagoe, Saitama, Japan
        • Saitama Medical Center
    • Tochigi
      • Utsunomiya, Tochigi, Japan
        • Tochigi Cancer Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Japan
        • The Cancer institute Hospital of Japanese Foundation for Cancer Research
      • Shinagawa, Tokyo, Japan
        • Toranornon Hospital
      • Shinjuku, Tokyo, Japan
        • Tokyo Medical University Hospital
      • Tachikawa, Tokyo, Japan
        • National Hospital Organization Disaster Medical Center
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of
        • Seoul Saint Mary's Hospital
    • Gyeonggi-Do
      • Incheon, Gyeonggi-Do, Korea, Republic of
        • Gachon University Gil Medical Center
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
    • Gyeongsangnam-Do
      • Busan, Gyeongsangnam-Do, Korea, Republic of
        • Pusan National University Hospital
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
    • Auckland
      • North Shore City, Auckland, New Zealand
        • North Shore Hospital
      • Otahuhu, Auckland, New Zealand
        • Middlemore Hospital
    • Aukland
      • Grafton, Aukland, New Zealand
        • Auckland City Hospital
  • Poland
    • Kujawsko-Pomorskie
      • Torun, Kujawsko-Pomorskie, Poland
        • Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
    • Lubelskie
      • Zamosc, Lubelskie, Poland
        • Zamojski Szpital Niepubliczny Sp. z o.o.
    • Malopolskie
      • Krakow, Malopolskie, Poland
        • Szpital Uniwersytecki w Krakowie
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland
        • Instytut Hematologii i Transfuzjologii
    • Pomorskie
      • Gdansk, Pomorskie, Poland
        • Uniwersyteckie Centrum Kliniczne
    • Slaskie
      • Chorzów, Slaskie, Poland
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland
        • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
  • Romania
      • Brasov, Romania
        • Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
      • Brasov, Romania
        • Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
      • Bucuresti, Romania
        • Institutul Clinic Fundeni
      • Iasi, Romania
        • Institutul Regional de Oncologie Iasi
    • Bucuresti
      • Bucharest, Bucuresti, Romania
        • Spitalul Universitar de Urgenta Bucuresti
  • Russian Federation
      • Izhevsk, Russian Federation
        • Republican Clinical Hospital #1
      • Moscow, Russian Federation
        • Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
      • Moscow, Russian Federation
        • City Clinical Hospital n.a. S. P. Botkin
      • Ryazan, Russian Federation
        • Ryazan Regional Clinical Hospital
      • Saint Petersburg, Russian Federation
        • Fgu Russian Scientific Research Institute of Hematology and Transfusiology
      • Saint Petersburg, Russian Federation
        • Federal Almazov Medical Research Centre
      • Saint Petersburg, Russian Federation
        • Clinical Hospital Number 31
      • Saint Petersburg, Russian Federation
        • First Saint Petersburg I.P. Pavlov State Medical University
      • Samara, Russian Federation
        • GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • National University Cancer Institute
      • Singapore, Singapore
        • Singapore Oncology Consultants
  • Slovakia
      • Bratislava, Slovakia
        • Univerzitna nemocnica Bratislava
  • Spain
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain
        • Institut Universitari Dexeus
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Princesa
      • Madrid, Spain
        • Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro
      • Salamanca, Spain
        • Hospital Clinico Universitario de Salamanca
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Baleares
      • Palma de Mallorca, Baleares, Spain
        • Hospital Son Llatzer
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Universitari Germans Trias i Pujol
  • Taiwan
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng-Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Tao-Yuan, Taiwan
        • Chang Gung Medical Foundation-Linkou Branch
  • Thailand
      • Khon Kaen, Thailand
        • Srinagarind Hospital
    • Bangkok Metropolis
      • Bangkok, Bangkok Metropolis, Thailand
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Bangkok Metropolis, Thailand
        • Ramathibodi hospital
  • Ukraine
      • Cherkassy, Ukraine
        • Cherkassy Regional Oncology Center
      • Dnipropetrovsk, Ukraine
        • MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
      • Donetsk, Ukraine
        • Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
      • Khmelnytsky, Ukraine
        • Khmelnytsky Regional Clinical Hospital
      • Khmelnytsky, Ukraine
        • Khmelnytsky Regional Hospital, Department of Hematology
      • Kiev, Ukraine
        • National Institute of Cancer, Oncohematology Department
      • Kyiv, Ukraine
        • Kyiv Bone Marrow Transplantation Center
      • Lviv, Ukraine
        • Lviv Regional Oncology Dispensary
      • Lviv, Ukraine
        • Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
      • Mykolayiv, Ukraine
        • Regional Clinical Hospital
    • Dnipropretrovsk
      • Dnepropetrovsk, Dnipropretrovsk, Ukraine
        • City Hematology Center
    • Kharkiv
      • Kharkov, Kharkiv, Ukraine
        • Municipal Institution of Health Protection "Clinical Hospital #8"
  • United Kingdom
    • England
      • London, England, United Kingdom
        • University College Hospital
      • London, England, United Kingdom
        • Royal Free Hospital
      • Manchester, England, United Kingdom
        • Manchester Royal Infirmary
      • Nottingham, England, United Kingdom
        • Nottingham University Hospitals NHS Trust
      • Oxford, England, United Kingdom
        • Churchill Hospital
      • Plymouth, England, United Kingdom
        • Derriford Hospital
      • Sheffield, England, United Kingdom
        • Royal Hallamshire Hospital
      • Surrey, England, United Kingdom
        • Royal Marsden Hospital
      • Wolverhampton, England, United Kingdom
        • Royal Wolverhampton Hospitals Trust
  • United States
    • California
      • Burbank, California, United States
        • Providence St. Joseph Medical Center
      • La Jolla, California, United States
        • UCSD Moore Cancer Center
      • Los Angeles, California, United States
        • UCLA Medical Center
      • Santa Maria, California, United States
        • Central Coast Medical Oncology Group
    • Colorado
      • Denver, Colorado, United States
        • Colorado Blood Cancer Institute
    • Florida
      • Melbourne, Florida, United States
        • MAB Oncology/Hematology
      • West Palm Beach, Florida, United States
        • Palm Beach Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States
        • Winship Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States
        • Hematology Oncology of Indiana, PC
    • Maryland
      • Bethesda, Maryland, United States
        • Center for Cancer and Blood Disorders
      • Rockville, Maryland, United States
        • Associates in Oncology/Hematology PC
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
    • Missouri
      • Kansas City, Missouri, United States
        • University of Kansas
    • New Jersey
      • Hackensack, New Jersey, United States
        • Hackensack University Medical Ctr
    • New York
      • Bronx, New York, United States
        • Montefiore Medical Center
      • New York, New York, United States
        • Weill Cornell Medical College
      • New York, New York, United States
        • Clinical Research Alliance Inc.
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Wake Forest University Health Sciences, Section on Hematology and Oncology
    • Ohio
      • Canton, Ohio, United States
        • Gabrail Cancer Center
      • Cincinnati, Ohio, United States
        • The Christ Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Western Pennsylvania Hospital
    • South Carolina
      • Greenville, South Carolina, United States
        • Hematology/Oncology Associates of SC
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt Ingram Cancer Center
    • Texas
      • Houston, Texas, United States
        • MD Anderson
      • Houston, Texas, United States
        • The Methodist Cancer Center
      • Temple, Texas, United States
        • Scott & White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah School of Medicine

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

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

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

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

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

Exclusion Criteria:

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

  16. Second malignancy within the past 3 years except:

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

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
Intervention / Treatment
Experimental: Carfilzomib plus Dexamethasone
Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
Drug: Carfilzomib
Carfilzomib is administered over 30 minutes as an infusion.
Other Names:
  • PR-171
  • Krypolis
Drug: Dexamethasone
Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.
Active Comparator: Bortezomib plus Dexamethasone
Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Drug: Dexamethasone
Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.
Drug: Bortezomib
Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively

Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).

Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.

Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).

Median overall survival was estimated using the Kaplan-Meier method.
From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.
Overall Response
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.

Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).

sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).

CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.

PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
Duration of Response
Time Frame: From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.
Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.
Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
Time Frame: From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.

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 study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline and 24 weeks

A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.

For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%.
Baseline and 24 weeks
Change From Baseline in Right Ventricular Fractional Area Change (FAC)
Time Frame: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.
Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)
Time Frame: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
Pulmonary artery pressure was measured using transthoracic echocardiogram.
Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).

Collaborators and Investigators

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

Sponsor

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)

June 20, 2012

Primary Completion (Actual)

November 10, 2014

Study Completion (Actual)

February 5, 2018

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-003
  • 2012-000128-16 (EudraCT Number)

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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