955
Participants
Start Date
July 8, 2013
Primary Completion Date
July 15, 2016
Study Completion Date
November 4, 2016
Carfilzomib
Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.
Bortezomib
Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.
Melphalan
Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
Prednisone
Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
National Taiwan University Hospital, Taipei
Auckland City Hospital, Auckland
St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant, Budapest
"National Institute of Oncology, Department of Oncology, Internal Medicine A and Hematology", Budapest
Vienna Wilhelminen Hospital, Vienna
Group Practice for Hematology and Oncology, Dresden
Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic, Sofia
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic, Sofia
St. Vincent's Hospital Sydney, Darlinghurst
Royal Prince Alfred Hospital, Camperdown
ZNA, Stuivenberg, Antwerp
Central Coast Local Health District, North Gosford
Calvary Mater Newcastle, Waratah
The Alfred Hospital, Melbourne
Eastern Health - Box Hill Hospital, Box Hill
Border Medical Oncology, Wodonga
CHR de La Citadelle (ENG: Citadelle Regional Hospital Center), Liège
"University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv, Hematology Clinic", Plovdiv
"University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv, Oncology and Hematology Clinic", Plovdiv
Elisabeth Linz Hospital, Linz
University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology, Debrecen
Royal Adelaide Hospital, Adelaide
CHU Mont-Godinne, Yvoir
Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology, Gyula
Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine, Kecskemét
Medical University of Innsbruck, University Clinic for Internal Medicine V, Innsbruck
Wellington Hospital, Wellington
Saint Joseph Clinic Arlon, Department of Hematology, Arlon
Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology, Kaposvár
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine, Pécs
Canterbury Health Laboratories, Christchurch
Hospital Universitari Germans Trias i Pujol, Badalona
"Multiprofile Hospital for Active Treatment Sveta Marina, Varna", Varna
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center, Zhytomyr
Weill Cornell Medical Center, New York
University Hospital Kralovske Vinohrady - Internal Hematology Clinic, Prague
AO Città della Salute e della Scienza di Torino, Division of Hematology, Torino
Evangelismos Hospital, Athens
University of Athens, Alexandra Hospital, Athens
CHU de Caen, Côte de Nacre, Caen
Cherkasy Regional Oncology Center, Cherkasy
M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department, Vinnitsya
Hospital Universitario 12 De Octubre, Madrid
Khmelnytskyi Regional Hospital, Hematology Department, Khmelnytskyi
Santee Hematology Oncology, Sumter
Spartanburg Regional Healthcare System, Spartanburg
Saint Francis Health System, Greenville
Rambam Medical Center, Department of Hematology, Haifa
Hospital Universitario, Salamanca, Salamanca
China Medical University Hospital, Taichung
Hospital Virgen del Rocio University, Seville
Nantes University Hospital Center, Nantes
Gabrail Cancer Center Research, Canton
Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología, Valencia
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre, Dnipropetrovsk
Bucharest Emergency University Hospital, Hematology Department, Bucharest
University Hospital Cologne, Cologne
Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine, Koblenz
CHRU Lille Hôpital Claude Huriez, Lille
Billings Clinic Cancer Center, Billings
Kharkiv Regional Clinical Oncology Center, Department of Hematology, Kharkiv
CHU Estaing, Clermont-Ferrand
South Lyon Hospital Center, Pierre-Bénite
Centre Hospitalier Lyon Sud, Service d'hématologie Clinique, Pierre-Bénite
Institute of Blood Pathology and Transfusion Medicine, Lviv
Innovative Clinical Research Institute, Whittier
Ein Kerem Hospital, Department of Hematology, Jerusalem
California Cancer Associates for Research & Excellence, Inc. (cCARE), Fresno
Marin Cancer Care, Greenbrae
Sutter Gould Medical Foundation, Modesto
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
National University Hospital, Singapore
City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders, Moscow
Singapore General Hospital, Singapore
State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology, Petrozavodsk
Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care, Saint Petersburg
City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders, Saint Petersburg
Singapore Oncology Consultants, Gleneagles Hospital, Singapore
"Prof. Dr. Ion Chiricuta Institut of Oncology, Hematology Department", Cluj-Napoca
State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia, Izhevsk
Brasov County Emergency Clinical Hospital, Hematology Department, Brasov
Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation, Târgu Mureş
Iasi Regional Institute for Oncology, Medical Hematology Department, Iași
UF Health Shands Cancer Hospital, Gainesville
Evanston KelIogg Cancer Center, Evanston
Maimonides Cancer Center, Brooklyn
Seattle Cancer Care Alliance, Seattle
"Centro de educacion medica c investigacioncs clinicas Norberto Quimo' (CEMIC)", Buenos Aires
Sanatorio Britanico S.A., Santa Fe
St. Vincent's Hospital Melbourne, Fitzroy
Royal North Shore Hospital, Haematology Department, New South Wales
CSSS-Champlain-Charles LeMoyne, Greenfield Park
Fujian Medical University Union Hospital, Fuzhou
Guangdong General Hospital, Guangzhou
Guangzhou First People's Hospital, Guangzhou
The First Affiliated Hospital of Soochow University, Suzhou
The First Hospital of Jilin University, Changchun
The First Affiliated Hospital of the Fourth Military Medical University of PLA, Xi’an
The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin, Hangzhou
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou
307 Hospital of PLA, Beijing
Beijing Chao Yang Hospital, Capital Medical University, Beijing
Peking Union Medical College Hospital, Beijing
Peking University Third Hospital, Beijing
Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai Changzheng Hospital, Shanghai
Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University, Tianjin
Tianjin Medical University Cancer Institute and Hospital, Tianjin
UHC Dijon, Children's Hospital, Dijon
CHRU Hopital Huriez, Departement of Hematology, Lille
Paoli Calmettes Institute, Department ofHematology 2, Marseille
Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau, Nîmes
Hopital Saini Louis, Service d'immuno-Hematologie, Paris
Hopital Saint Antoine, Paris
Hospital Necker, Paris
Hopital Pontchaillou, Rennes
Hospital Purpan, Toulouse
CHU de Tours Hopital Bretonneau, Tours
Freiburg University Medical Center, Freiburg im Breisgau
Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III, Ulm
Ludwig Maximilians University Hospital - Medical Clinic III, Munich
Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III, Mainz
Saarland University Hospital, Homburg / Saar
The Chaim Sheba Medical Center, Tel Litwinsky
UO Clinica Ematologica, IRCCS A.O.U. San Martino, Genova
A.O.U. San Luigi Gonzaga, Orbassano
Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi, Ancona
Maggiore della Carita Hospital of Novara, Novara
Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema, Piacenza
Ospedale S. Eugenio, Roma
"Policlinico Universitario Umberto I", Rome
Nagoya City University Hospital, Nagoya
Toyohashi Municipal Hospital, Toyohashi
Kyushu University Hospital, Fukuoka
National Hospitalization Organization Kyushu Cancer Center, Minamiku
Ogaki Municipal Hospital, Ōgaki
Gunma University Hospital, Maebashi
Sapporo Medical University Hospital, Sapporo
National Hospital Organization Okayama Medical Center, Okayama
Osaka University Hospital, Suita
Japanese Red Cross Medical Center, Tokyo
Tochigi Cancer Center, Utsunomiya
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Koto
National Center for Global Health and Medicine, Shinjuku
National Hospital Organization Disaster Medical Center, Tachikawa
University Hospital, Kyoto Prefectural University of Medicine, Kyoto
Tokushima Prefectural Central Hospital, Tokushima
"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey
Fundacion Centro Oncologieo de Integracion Regional - COIR, Mendoza
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City
Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles, Puebla City
Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology, Amsterdam
St. Antonius Ziekenhuis, Department of Hematology, Nieuwegein
Erasmus Medical Center, Rotterdam
Isala Clinics in Zwolle, Department of Oncology, Zwolle
Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn, Olsztyn
Independent Public Healthcare Facility University Hospital, Krakow
Nicolaus Copernicus Memorial Provincial Specialist Hospital, Lodz
Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology, Lublin
Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2, Arkhangelsk
State Higher Educational Institution St. Petersburg Pavlov State Medical University, Saint Petersburg
The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian, Saint Petersburg
OncoCare Cancer Center, Singapore
Singapore General Hospital, Singapore
National Cancer Center, Goyang-si
University Hospital of Navarra, Pamplona
Hospital Clinic i Provincial Barcelona, Barcelona
Hospital Quiron Zaragoza, Zaragoza
University Hospital Center Vaudois, Lausanne
County Hospital Saint Gallen, Sankt Gallen
Changhua Christian Hospital, Changhua
Kuohsiung Chang Gung Memorial Hospital, Kaohsiung City
Taipei Veterans General Hospital, Taipei
Chang-Gung Memorial Hospital, Linkou, Tapei
Ege University Medical Faculty, Izmir
Marmara University Pendik Training and Research Hospital, Istanbul
Poltava M.V. Sklifosovskyi Regional Clinical-Hospital, Poltava
A. Novak Zakarpattia Regional Clinical Hospital, Uzhhorod
Northwick Park Hospital, Harrow
University Hospital Brno, Department of Internal Hematology and Oncology, Brno
University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis, Brno
University Hospital Hradec Kralove, Hradec Králové
University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology, Olomouc
University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO, Ostrava
General University Hospital Prague, 1st Department of Medicine - Department of Hematology, Prague
Soroka University Medical Center, Beersheba
North Shore Hospital, Auckland
Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology, Chorzów
Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Katowice
Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology, Torun
Maria Sklodowska-Curie Institute of Oncology, Warsaw
Fundeni Clinical Institute, Hematology Department, Bucharest
Coltea Clinical Hospital, Hematology Department, Bucharest
Seoul National University Bundang Hospital, Seongnam-si
Chonnam National University Hwasun Hospital, Hwasun-gun
Pusan National University Hospital, Busan
Inje University Busan Paik Hospital, Busan
Kyungpook National University Hospital, Daegu
Gachon University Gil Medical Center, Incheon
Seoul National University Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Samsung Medical Center, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Asan Medical Center, Seoul
Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department, Ankara
Kyiv Center for Bone Marrow Transplantation, Kyiv
Kent and Canterbury Hospital, Canterbury
Maidstone Hospital, Kent Oncology Centre, Maidstone
Raigmore Hospital, Inverness
University College London, Cancer Centre, London
Guy's and St. Thomas' NHS Foundation Trust, London
Oxford University Hospitals NHS Trust, Churchill Hospital, Oxford
The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital, Wolverhampton
Lead Sponsor
Amgen
INDUSTRY