Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
CLARION
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
3 other identifiers
interventional
955
29 countries
203
Brief Summary
The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
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 Jul 2013
Shorter than P25 for phase_3 multiple-myeloma
203 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
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2013
CompletedStudy Start
First participant enrolled
July 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2016
CompletedResults Posted
Study results publicly available
August 1, 2017
CompletedAugust 26, 2019
August 1, 2019
3 years
February 12, 2013
July 3, 2017
August 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression. Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner.
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 Outcomes (6)
Overall Survival (OS)
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
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
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
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
Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
- +1 more secondary outcomes
Study Arms (2)
Carfilzomib, Melphalan, Prednisone
EXPERIMENTALParticipants 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.
Bortezomib, Melphalan, Prednisone
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
Eligibility Criteria
You may qualify if:
- Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group \[IMWG\] diagnostic criteria)
- Transplant ineligibility
- Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):
- Serum M-protein ≥ 0.5 g/dL, or
- Urine M-protein ≥ 200 mg/24 hours, or
- In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio \< 0.26 or \> 1.65)
- No prior treatment for multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
You may not qualify if:
- Multiple myeloma of IgM (immunoglobulin M) subtype
- Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
- Waldenström macroglobulinemia (WM)
- Known amyloidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (213)
California Cancer Associates for Research & Excellence, Inc. (cCARE)
Fresno, California, 93720, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
Sutter Gould Medical Foundation
Modesto, California, 95357, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
UF Health Shands Cancer Hospital
Gainesville, Florida, United States
Evanston KelIogg Cancer Center
Evanston, Illinois, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Saint Francis Health System
Greenville, South Carolina, 29601, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303, United States
Santee Hematology Oncology
Sumter, South Carolina, 29150, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)
Buenos Aires, Argentina
Sanatorio Britanico S.A.
Santa Fe, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Central Coast Local Health District
North Gosford, New South Wales, 2250, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Eastern Health - Box Hill Hospital
Box Hill, Victoria, 3128, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Border Medical Oncology
Wodonga, Victoria, 3690, Australia
Royal North Shore Hospital, Haematology Department
New South Wales, Australia
Medical University of Innsbruck, University Clinic for Internal Medicine V
Innsbruck, 6020, Austria
Elisabeth Linz Hospital
Linz, 4020, Austria
Vienna Wilhelminen Hospital
Vienna, 1160, Austria
ZNA, Stuivenberg
Antwerp, Antwerpen, 2060, Belgium
Saint Joseph Clinic Arlon, Department of Hematology
Arlon, Luxembourg, 6700, Belgium
CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)
Liège, 4000, Belgium
CHU Mont-Godinne
Yvoir, 5530, Belgium
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic
Plovdiv, 4002, Bulgaria
Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic
Sofia, 1606, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic
Sofia, 1756, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina", Varna
Varna, 9010, Bulgaria
CSSS-Champlain-Charles LeMoyne
Greenfield Park, Quebec, Canada
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of the Fourth Military Medical University of PLA
Xi’an, Shanxi, China
The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin
Hangzhou, Zhejiang, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
307 Hospital of PLA
Beijing, China
Beijing Chao Yang Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Changzheng Hospital
Shanghai, China
Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University
Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
University Hospital Brno, Department of Internal Hematology and Oncology
Brno, 625 00, Czechia
University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis
Brno, 625 00, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology
Olomouc, 775 20, Czechia
University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO
Ostrava, 708 52, Czechia
University Hospital Kralovske Vinohrady - Internal Hematology Clinic
Prague, 10034, Czechia
General University Hospital Prague, 1st Department of Medicine - Department of Hematology
Prague, 128 08, Czechia
CHU de Caen, Côte de Nacre
Caen, 14033, France
CHU Estaing
Clermont-Ferrand, 63000, France
UHC Dijon, Children's Hospital
Dijon, France
CHRU Lille Hôpital Claude Huriez
Lille, 59037, France
CHRU Hopital Huriez, Departement of Hematology
Lille, France
Paoli Calmettes Institute, Department ofHematology 2
Marseille, France
Nantes University Hospital Center
Nantes, 44093, France
Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau
Nîmes, France
Hopital Saini Louis, Service d'immuno-Hematologie
Paris, France
Hopital Saint Antoine
Paris, France
Hospital Necker
Paris, France
South Lyon Hospital Center
Pierre-Bénite, 69310, France
Centre Hospitalier Lyon Sud, Service d'hématologie Clinique
Pierre-Bénite, 69495, France
Hopital Pontchaillou
Rennes, France
Hospital Purpan
Toulouse, France
CHU de Tours Hopital Bretonneau
Tours, France
Freiburg University Medical Center
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III
Ulm, Baden-Wurttemberg, Germany
Ludwig Maximilians University Hospital - Medical Clinic III
Munich, Bavaria, Germany
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937, Germany
Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III
Mainz, Rhineland-Palatinate, Germany
Saarland University Hospital
Homburg / Saar, Saarland, Germany
Group Practice for Hematology and Oncology
Dresden, 1307, Germany
Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine
Koblenz, 56068, Germany
Evangelismos Hospital
Athens, Attica, 10676, Greece
University of Athens, Alexandra Hospital
Athens, 11528, Greece
St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant
Budapest, 1097, Hungary
National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology
Budapest, 1122, Hungary
University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology
Debrecen, 4032, Hungary
Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology
Gyula, 5700, Hungary
Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology
Kaposvár, 7400, Hungary
Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine
Kecskemét, 6000, Hungary
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
Pécs, 7624, Hungary
Soroka University Medical Center
Beersheba, P.O.B 151, Israel
Rambam Medical Center, Department of Hematology
Haifa, 31096, Israel
Ein Kerem Hospital, Department of Hematology
Jerusalem, 91120, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
UO Clinica Ematologica, IRCCS A.O.U. San Martino
Genova, GE, Italy
A.O.U. San Luigi Gonzaga
Orbassano, TO, Italy
Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi
Ancona, Italy
Maggiore della Carita Hospital of Novara
Novara, Italy
Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema
Piacenza, Italy
Ospedale S. Eugenio
Roma, Italy
Policlinico Universitario "Umberto I"
Rome, Italy
AO Città della Salute e della Scienza di Torino, Division of Hematology
Torino, 10126, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
National Hospitalization Organization Kyushu Cancer Center
Minamiku, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
Osaka University Hospital
Suita, Osaka, Japan
Japanese Red Cross Medical Center
Tokyo, Shibuya-ku, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto, Tokyo, Japan
National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Tokushima Prefectural Central Hospital
Tokushima, Japan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Fundacion Centro Oncologieo de Integracion Regional - COIR
Mendoza, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico
Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles
Puebla City, Mexico
Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology
Amsterdam, Netherlands
St. Antonius Ziekenhuis, Department of Hematology
Nieuwegein, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Isala Clinics in Zwolle, Department of Oncology
Zwolle, Netherlands
North Shore Hospital
Auckland, 0622, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Canterbury Health Laboratories
Christchurch, 8011, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn
Olsztyn, OIsztyn, Poland
Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology
Chorzów, Silesian Voivodeship, 41-500, Poland
Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
Katowice, 40-032, Poland
Independent Public Healthcare Facility University Hospital
Krakow, Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital
Lodz, Poland
Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology
Lublin, Poland
Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology
Torun, 87-100, Poland
Maria Sklodowska-Curie Institute of Oncology
Warsaw, 02-781, Poland
"Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department
Cluj-Napoca, Cluj, 400124, Romania
Iasi Regional Institute for Oncology, Medical Hematology Department
Iași, Iaşi, 700483, Romania
Brasov County Emergency Clinical Hospital, Hematology Department
Brasov, 500326, Romania
Fundeni Clinical Institute, Hematology Department
Bucharest, 022 328, Romania
Coltea Clinical Hospital, Hematology Department
Bucharest, 030 171, Romania
Bucharest Emergency University Hospital, Hematology Department
Bucharest, 50098, Romania
Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation
Târgu Mureş, 540042, Romania
State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology
Petrozavodsk, Republic of Karelia, 185019, Russia
Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2
Arkhangelsk, Russia
State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
Izhevsk, 426039, Russia
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, 115478, Russia
City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
Moscow, 125284, Russia
Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care
Saint Petersburg, 191024, Russia
City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
Saint Petersburg, 197110, Russia
State Higher Educational Institution St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia
The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian
Saint Petersburg, Russia
National University Hospital
Singapore, 119228, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Singapore Oncology Consultants, Gleneagles Hospital
Singapore, 258500, Singapore
OncoCare Cancer Center
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 519-763, South Korea
Pusan National University Hospital
Busan, 602-739, South Korea
Inje University Busan Paik Hospital
Busan, 614-735, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Seoul National University Hospital
Seoul, 110-774, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barselona, 8916, Spain
University Hospital of Navarra
Pamplona, Navarre, Spain
Hospital Clinic i Provincial Barcelona
Barcelona, Spain
Hospital Universitario 12 De Octubre
Madrid, 28041, Spain
Hospital Universitario, Salamanca
Salamanca, 37007, Spain
Hospital Virgen del Rocio University
Seville, 41013, Spain
Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología
Valencia, 46026, Spain
Hospital Quiron Zaragoza
Zaragoza, Spain
University Hospital Center Vaudois
Lausanne, Switzerland
County Hospital Saint Gallen
Sankt Gallen, Switzerland
Changhua Christian Hospital
Changhua, Taiwan
Kuohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang-Gung Memorial Hospital, Linkou
Tapei, Taiwan
Ege University Medical Faculty
Izmir, Bornova, Turkey (Türkiye)
Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department
Ankara, Cebeci, 06590, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, Turkey (Türkiye)
Cherkasy Regional Oncology Center
Cherkasy, 18009, Ukraine
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre
Dnipropetrovsk, 49102, Ukraine
Kharkiv Regional Clinical Oncology Center, Department of Hematology
Kharkiv, 61070, Ukraine
Khmelnytskyi Regional Hospital, Hematology Department
Khmelnytskyi, 29000, Ukraine
Kyiv Center for Bone Marrow Transplantation
Kyiv, 03 115, Ukraine
Institute of Blood Pathology and Transfusion Medicine
Lviv, 79044, Ukraine
Poltava M.V. Sklifosovskyi Regional Clinical-Hospital
Poltava, Ukraine
A. Novak Zakarpattia Regional Clinical Hospital
Uzhhorod, Ukraine
M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department
Vinnitsya, 21018, Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center
Zhytomyr, 10002, Ukraine
Kent and Canterbury Hospital
Canterbury, Kent, CTI 3NG, United Kingdom
Maidstone Hospital, Kent Oncology Centre
Maidstone, Kent, ME16 9QQ, United Kingdom
Northwick Park Hospital
Harrow, Middlesex, United Kingdom
Raigmore Hospital
Inverness, IV2 3UJ, United Kingdom
University College London, Cancer Centre
London, NW1 2PG, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Oxford University Hospitals NHS Trust, Churchill Hospital
Oxford, OX3 7LE, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (3)
Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.
PMID: 29991494BACKGROUNDFacon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.
PMID: 30819926BACKGROUNDRosenthal 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: 26771810DERIVED
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
February 12, 2013
First Posted
March 26, 2013
Study Start
July 8, 2013
Primary Completion
July 15, 2016
Study Completion
November 4, 2016
Last Updated
August 26, 2019
Results First Posted
August 1, 2017
Record last verified: 2019-08