454
Participants
Start Date
May 8, 2019
Primary Completion Date
March 31, 2023
Study Completion Date
March 31, 2023
Carfilzomib
Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
Carfilzomib
Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
Lenalidomide
Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
Dexamethasone
Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD, Sofia
Specialized Hospital for Active Treatment of Hematology Diseases EAD, Sofia
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv
Universitaetsklinikum Salzburg, Salzburg
General Hospital Evangelismos, Athens
251 General Airforce Hospital, Athens
Alexandra Hospital, Athens
Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin, Berlin
New York Oncology Hematology, PC, Albany
Metropolitan Hospital, Athens
Universitatsklinikum Hamburg-Eppendorf, Hamburg
Turun Yliopistollinen Keskussairaala, Turku
General University Hospital of Patras Panagia i Voithia, Pátrai
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón
Clinica Universidad de Navarra, Pamplona
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse
Baptist MD Anderson Cancer Center, Jacksonville
Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul
Bagcilar Medipol Mega Universite Hastanesi, Istanbul
Istanbul Florence Nightingale Hastanesi, Istanbul
Centre Hospitalier Universitaire de Rennes, Rennes
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi, Izmir
Hospital Clinico Universitario de Salamanca, Salamanca
Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi, Kayseri
Centre Hospitalier Universitaire de Nantes, Nantes
Oncology Hematology Care Inc, Cincinnati
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution, Kaunas
Universitatsklinikum Koln, Cologne
Theagenion Cancer Hospital of Thessaloniki, Thessaloniki
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy
Johannes Gutenberg Universitaet Mainz, Mainz
General Hospital of Thessaloniki Georgios Papanikolaou, Thessaloniki
Advocate Lutheran General Hospital, Park Ridge
Institut de Cancerologie Strasbourg, Strasbourg
University Hospital of Alexandroupolis, Alexandroupoli
Centre Hospitalier Lyon Sud, Pierre-Bénite
Hopital Saint Louis, Paris
Hopital Pitie-Salpetriere, Paris
US Oncology Research Investigational Products Center, Fort Worth
Texas Oncology-Denton, Denton
Oncology Consultants PA, Houston
United States Oncology Regulatory Affairs Corporate Office, The Woodlands
Texas Oncology, San Antonio
Rocky Mountain Cancer Centers Denver Midtown, Denver
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie, Poitiers
Oulun Yliopistollinen Sairaala, Oulu
Robert A Moss Oncology, Fountain Valley
Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department, Moscow
SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department, Moscow
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov, Petrozavodsk
Federal centre of heart, blood and endocrinology Almazova, Saint Petersburg
Spitalul Clinic Municipal de Urgenta Timisoara, Timișoara
Institutul Oncologic Prof Dr Ion Chiricuta, Cluj-Napoca
Spitalul Clinic Dr Gavril Curteanu Oradea, Oradea
State Budget Educational Institution of High Professional Skills Samara State Medical University, Samara
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu
Regional Clinical Hospital, Krasnoyarsk
Institutul Regional de Oncologie Iasi, Iași
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut, Plainville
Fakultni nemocnice Brno, Brno
Fakultni nemocnice Hradec Kralove, Hradec Králové
Fakultni nemocnice Olomouc, Olomouc
Vseobecna fakultni nemocnice v Praze, Prague
Helsingin Yliopistollinen Keskussairaala, Helsinki
Centre Hospitalier Universitaire Archet 2, Nice
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Dresden
Agios Savvas Anticancer Hospital, Athens
Nagoya City University Hospital, Nagoya
Toyohashi Municipal Hospital, Toyohashi
Tesshokai Kameda General Hospital, Kamogawa-shi
National Hospital Organization Kyushu Cancer Center, Fukuoka
Ogaki Municipal Hospital, Ogaki-shi
National Hospital Organization Shibukawa Medical Center, Shibukawa-shi
Japanese Red Cross Society Himeji Hospital, Himeji-shi
Hyogo College of Medicine Hospital, Nishinomiya-shi
Hitachi Ltd Hitachi General Hospital, Hitachi-shi
University Hospital Kyoto Prefectural University of Medicine, Kyoto
National Hospital Organization Sendai Medical Center, Sendai
Niigata Cancer Center Hospital, Niigata
National Hospital Organization Okayama Medical Center, Okayama
Japanese Red Cross Osaka Hospital, Osaka
Kindai University Hospital, Osakasayama-shi
Osaka University Hospital, Suita-shi
Saitama Medical Center, Kawagoe-shi
Tochigi Cancer Center, Utsunomiya
Juntendo University Hospital, Bunkyo-ku
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku
Japanese Red Cross Medical Center, Shibuya-ku
Vilnius University Hospital Santaros Clinic Public Institution, Vilnius
VU Medisch Centrum, Amsterdam
Gelre Ziekenhuizen, Apeldoorn
Spaarne Gasthuis, Hoofddorp
Spitalul Clinic Colentina, Bucharest
Fundeni Clinical Institute, Bucharest
Institutul Clinic Fundeni, Bucharest
Spitalul Clinic Coltea, Bucharest
Spitalul Universitar de Urgenta Bucuresti, Bucharest
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda, Bratislava
Hospital Universitari Son Espases, Palma de Mallorca
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Clinic i Provincial de Barcelona, Barcelona
Falu Lasarett, Falun
Sahlgrenska Universitetssjukhuset, Gothenburg
Hallands Sjukhus Halmstad, Halmstad
Sunderby Sjukhus, Luleå
Skanes Universitetssjukhus, Lund
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi, Ankara
Lead Sponsor
Amgen
INDUSTRY