Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
ENDEAVOR
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
2 other identifiers
interventional
929
26 countries
220
Brief Summary
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Jun 2012
220 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedStudy Start
First participant enrolled
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2014
CompletedResults Posted
Study results publicly available
December 11, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2018
CompletedNovember 14, 2022
November 1, 2022
2.4 years
March 28, 2012
November 6, 2015
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.
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 Outcomes (7)
Overall Survival
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
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
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
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)
Baseline and 24 weeks
- +2 more secondary outcomes
Study Arms (2)
Carfilzomib plus Dexamethasone
EXPERIMENTALParticipants 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.
Bortezomib plus Dexamethasone
ACTIVE COMPARATORParticipants 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.
Interventions
Carfilzomib is administered over 30 minutes as an infusion.
Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
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.
Eligibility Criteria
You may qualify if:
- Multiple myeloma with relapsing or progressing disease at study entry.
- Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):
- Serum M-protein ≥ 0.5 g/dL, or
- Urine M-protein ≥ 200 mg/24 hour, or
- In patients without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or
- For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL).
- Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
- Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
- Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
- Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
- Males and females ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Adequate hepatic function within 21 days prior to randomization, with bilirubin \< 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the ULN.
- Left ventricular ejection fraction (LVEF) ≥ 40%.
- Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
- +7 more criteria
You may not qualify if:
- Multiple Myeloma of IgM subtype.
- Glucocorticoid therapy (prednisone \> 30 mg/day or equivalent) within 14 days prior to randomization.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Plasma cell leukemia or circulating plasma cells ≥ 2 × 10\^9/L.
- Waldenstrom's Macroglobulinemia.
- Patients with known amyloidosis.
- Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
- Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
- Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
- Immunotherapy within 21 days prior to randomization.
- Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
- Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
- Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
- Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
- Patients with known cirrhosis.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (241)
Providence St. Joseph Medical Center
Burbank, California, United States
UCSD Moore Cancer Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Central Coast Medical Oncology Group
Santa Maria, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
MAB Oncology/Hematology
Melbourne, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Hematology Oncology of Indiana, PC
Indianapolis, Indiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Associates in Oncology/Hematology PC
Rockville, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Kansas
Kansas City, Missouri, United States
Hackensack University Medical Ctr
Hackensack, New Jersey, United States
Clinical Research Alliance Inc.
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences, Section on Hematology and Oncology
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Hematology/Oncology Associates of SC
Greenville, South Carolina, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
The Methodist Cancer Center
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St. Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia
Saint George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, 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 Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Saint Vincent's Hospital
East Melbourne, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz, Upper Austria, Austria
Wilhelminenspital der Stadt Wien
Vienna, Vienna, Austria
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Clínica de Oncologia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hemocentro Campinas-Unicamp
Campinas, São Paulo, 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
Rio de Janeiro, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Military Medical Academy Hospital for Active Treatment
Sofia, Sofia, Bulgaria
Shato, Ead
Sofia, Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment, "Sveta Marina''
Varna, Bulgaria
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Fakultní nemocnice Královské Vinohrady
Prague, Prague, Czechia
Fakultní nemocnice Olomouc
Olomouc, Severomoravsky KRAJ, Czechia
FN Ostrava
Ostrava, Severomoravsky KRAJ, Czechia
Fakultní nemocnice Hradec Králové
Hradec Kralové, Vychodocesky KRAJ, Czechia
Fakultní nemocnice Brno
Brno, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
Centre Hospitalier de la Cote Basque
Bayonne, Aquitaine, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire Brest
Brest, Brittany Region, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, Brittany Region, France
Hopital Hotel-Dieu - Service d'Hematologie
Nantes, Cedex 1, France
Centre Henri-Becquerel
Rouen, Haute-normandie, France
Hôpital Claude Huriez
Lille, Hauts-de-France, France
Hôpital Hôtel-Dieu
Nantes, Pays de la Loire Region, France
Institut Paoli Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de Versailles
Le Chesnay, Île-de-France Region, France
Hôpital Saint Louis
Paris, Île-de-France Region, France
Hôpital Saint-Antoine
Paris, Île-de-France Region, France
Universitätsklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Medizinische Klinik der Universität Würzburg
Würzburg, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
Dresden, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
Alexandra General Hospital
Athens, Attica, Greece
Pécsi Tudományegyetem
Pécs, Baranya, Hungary
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
Kecskemét, Bács-Kiskun county, Hungary
Szegedi Tudományegyetem
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Egyesített Szent István és Szent László Kórház-Rendelointézet
Budapest, Hungary
Somogy Megyei Kaposi Mac okato Korhoz
Kaposvár, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary
Rambam Health Corp.
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
The Chaim Sheba Medical Center at Tel Hashomer
Tel Litwinsky, Israel
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, Italy
Azienda Ospedaliera Universitaria Maggiore della Carità
Novara, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, Italy
Azienda Ospedaliera Pisana Ospedale Santa Chiara
Pisa, Italy
Aienda Policknico Umberto I di Roma
Roma, Italy
Azienda Policknico Umberto l di Roma
Roma, Italy
Università Tor Vergata Ospedale Sant Eugenio
Roma, Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Nishigunma National Hospital
Shibukawa, Gunma, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Osaka University Hospital
Suita, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of Japanese Foundation For Cancer Research
Koto-ku, Tokyo, Japan
Toranornon Hospital
Shinagawa, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku, Tokyo, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
Kyoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Tokushima Prefectural Central Hospital
Tokushima, Japan
Japanese Red Cross Medical Center
Tokyo, Japan
North Shore Hospital
North Shore, Auckland, New Zealand
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Auckland City Hospital
Grafton, Aukland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Zamojski Szpital Niepubliczny Sp. z o.o.
Zamość, Lublin Voivodeship, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, Silesian Voivodeship, Poland
Spitalul Universitar de Urgenta Bucuresti
Bucharest, București, Romania
Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
Brasov, Romania
Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
Brasov, Romania
Institutul Clinic Fundeni
Bucharest, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
Republican Clinical Hospital #1
Izhevsk, Russia
City Clinical Hospital n.a. S. P. Botkin
Moscow, Russia
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
Moscow, Russia
Ryazan Regional Clinical Hospital
Ryazan, Russia
Clinical Hospital Number 31
Saint Petersburg, Russia
Federal Almazov Medical Research Centre
Saint Petersburg, Russia
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, Russia
First Saint Petersburg I.P. Pavlov State Medical University
Saint Petersburg, Russia
GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
Samara, Russia
National University Cancer Institute
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Singapore Oncology Consultants
Singapore, Singapore
Univerzitná nemocnica Bratislava
Bratislava, Slovakia
Gachon University Gil Medical Center
Incheon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital
Pusan, Gyeongsangnam-do, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul Saint Mary's Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
Institut Universitari Dexeus
Barcelona, Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, Spain
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-LinKou Branch
Taoyuan District, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok Metropolis, Thailand
Ramathibodi Hospital
Bangkok, Bangkok Metropolis, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
City Hematology Center
Dnipro, Dnipropretrovsk, Ukraine
Municipal Institution of Health Protection "Clinical Hospital #8"
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Cherkassy Regional Oncology Center
Cherkassy, Ukraine
MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
Dnipropetrovsk, Ukraine
Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
Donetsk, Ukraine
Khmelnytsky Regional Clinical Hospital
Khmelnytsky, Ukraine
Khmelnytsky Regional Hospital, Department of Hematology
Khmelnytsky, Ukraine
National Institute of Cancer, Oncohematology Department
Kiev, Ukraine
Kyiv Bone Marrow Transplantation Center
Kyiv, Ukraine
Lviv Regional Oncology Dispensary
Lviv, Ukraine
Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
Lviv, Ukraine
Regional Clinical Hospital
Mykolayiv, Ukraine
Royal Free Hospital
London, England, United Kingdom
University College Hospital
London, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Royal Marsden Hospital
Surrey, England, United Kingdom
Royal Wolverhampton Hospitals Trust
Wolverhampton, England, United Kingdom
Related Publications (21)
Moreau P, Joshua D, Chng WJ, Palumbo A, Goldschmidt H, Hajek R, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Dimopoulos MA. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017 Jan;31(1):115-122. doi: 10.1038/leu.2016.186. Epub 2016 Jul 4.
PMID: 27491641BACKGROUNDChng WJ, Goldschmidt H, Dimopoulos MA, Moreau P, Joshua D, Palumbo A, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Feng S, Aggarwal S, Hajek R. Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. Leukemia. 2017 Jun;31(6):1368-1374. doi: 10.1038/leu.2016.390. Epub 2016 Dec 27.
PMID: 28025582BACKGROUNDDimopoulos MA, Goldschmidt H, Niesvizky R, Joshua D, Chng WJ, Oriol A, Orlowski RZ, Ludwig H, Facon T, Hajek R, Weisel K, Hungria V, Minuk L, Feng S, Zahlten-Kumeli A, Kimball AS, Moreau P. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1327-1337. doi: 10.1016/S1470-2045(17)30578-8. Epub 2017 Aug 23.
PMID: 28843768BACKGROUNDLudwig H, Dimopoulos MA, Moreau P, Chng WJ, Goldschmidt H, Hajek R, Facon T, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Palumbo A, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Joshua D. Carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma: results of the phase 3 study ENDEAVOR (NCT01568866) according to age subgroup. Leuk Lymphoma. 2017 Oct;58(10):2501-2504. doi: 10.1080/10428194.2017.1298755. Epub 2017 Mar 17. No abstract available.
PMID: 28306371BACKGROUNDChari 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.
PMID: 29991494BACKGROUNDDimopoulos M, Siegel D, White DJ, Boccia R, Iskander KS, Yang Z, Kimball AS, Mezzi K, Ludwig H, Niesvizky R. Carfilzomib vs bortezomib in patients with multiple myeloma and renal failure: a subgroup analysis of ENDEAVOR. Blood. 2019 Jan 10;133(2):147-155. doi: 10.1182/blood-2018-06-860015. Epub 2018 Nov 26.
PMID: 30478094BACKGROUNDFacon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.
PMID: 33166401BACKGROUNDHari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.
PMID: 28439109BACKGROUNDLeleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.
PMID: 30287200BACKGROUNDLudwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, Feng S, Cocks K, Buchanan J, Weisel K. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019 Feb 22;9(3):23. doi: 10.1038/s41408-019-0181-0.
PMID: 30796199BACKGROUNDMateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.
PMID: 29446103BACKGROUNDMoreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.
PMID: 32108443BACKGROUNDDimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.
PMID: 31388932BACKGROUNDGoldschmidt H, Moreau P, Ludwig H, Niesvizky R, Chng WJ, Joshua D, Weisel K, Spencer A, Orlowski RZ, Feng S, Iskander KS, Dimopoulos MA. Carfilzomib-dexamethasone versus subcutaneous or intravenous bortezomib in relapsed or refractory multiple myeloma: secondary analysis of the phase 3 ENDEAVOR study. Leuk Lymphoma. 2018 Jun;59(6):1364-1374. doi: 10.1080/10428194.2017.1376743. Epub 2017 Sep 22.
PMID: 28937327BACKGROUNDJakubowiak AJ, Houisse I, Majer I, Benedict A, Campioni M, Panjabi S, Ailawadhi S. Cost-effectiveness of carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone for patients with relapsed or refractory multiple myeloma in the United States. Expert Rev Hematol. 2017 Dec;10(12):1107-1119. doi: 10.1080/17474086.2017.1391088.
PMID: 29027825BACKGROUNDWeisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.
PMID: 33067574BACKGROUNDWeisel K, Majer I, DeCosta L, Oriol A, Goldschmidt H, Ludwig H, Campioni M, Szabo Z, Dimopoulos M. Carfilzomib and dexamethasone versus eight cycles of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma: an indirect comparison using data from the phase 3 ENDEAVOR and CASTOR trials. Leuk Lymphoma. 2020 Jan;61(1):37-46. doi: 10.1080/10428194.2019.1648806. Epub 2019 Oct 22.
PMID: 31640435BACKGROUNDOrlowski RZ, Moreau P, Niesvizky R, Ludwig H, Oriol A, Chng WJ, Goldschmidt H, Yang Z, Kimball AS, Dimopoulos M. Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups. Clin Lymphoma Myeloma Leuk. 2019 Aug;19(8):522-530.e1. doi: 10.1016/j.clml.2019.04.018. Epub 2019 May 2.
PMID: 31160237BACKGROUNDMajer IM, Castaigne JG, Palmer S, DeCosta L, Campioni M. Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology. Pharmacoeconomics. 2019 May;37(5):727-737. doi: 10.1007/s40273-018-0759-6.
PMID: 30610657DERIVEDRosenthal 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.
PMID: 26771810DERIVEDDimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hajek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosinol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5.
PMID: 26671818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2012
First Posted
April 2, 2012
Study Start
June 20, 2012
Primary Completion
November 10, 2014
Study Completion
February 5, 2018
Last Updated
November 14, 2022
Results First Posted
December 11, 2015
Record last verified: 2022-11