466
Participants
Start Date
June 13, 2017
Primary Completion Date
July 14, 2019
Study Completion Date
April 15, 2022
Dexamethasone
Commercially available oral and IV formulas were obtained by investigative sites. Amgen supplied IV or PO dexa for some countries (Poland, Hungry, Romania, Bulgaria, Korea). Dosage modification rules applied based on participant age (participants \> 75 years were given lower doses), dexa-related toxicities, and discontinuation of carfilzomib.
Daratumumab
Daratumumab was supplied as a concentrated solution for infusion in single-use vials.
Carfilzomib
"Carfilzomib for infusion was supplied as a lyophilized, sterile product in single-use vials. The lyophilized product was reconstituted with preservative-free sterile water for injection, the reconstituted solution contained carfilzomib 2 mg/mL. IV injections lasted approximately 30 minutes.~Dose could be modified based on a \>20% change in body weight or toxicity."
Semmelweis Egyetem, Budapest
Universitair Ziekenhuis Brussel, Brussels
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD, Sofia
Specialized Hospital for Active Treatment of Hematology Diseases EAD, Sofia
Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp
St Vincents Hospital Sydney, St Leonards
Westmead Hospital, Westmead
Liverpool Hospital, Liverpool
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven
Epworth Healthcare, East Melbourne
The Alfred Hospital, Melbourne
St Vincents Hospital Melbourne, Fitzroy, VIC
Barwon Health, University Hospital Geelong, Geelong
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv
Royal Brisbane and Womens Hospital, Herston
Debreceni Egyetem Klinikai Kozpont, Debrecen
Princess Alexandra Hospital, Woolloongabba
Royal Adelaide Hospital, Adelaide
Landeskrankenhaus Salzburg, Salzburg
Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz, Békéscsaba
Grand Hôpital de Charleroi, Charleroi
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged
Medizinische Universitaet Graz, Graz
Universitair Ziekenhuis Gent, Ghent
National Taiwan University Hospital, Taipei
New York Presbyterian Hospital, Weill Cornell Medical College, New York
National Cancer Center, Goyang-si, Gyeonggi-do
General Hospital Evangelismos, Athens
Taipei Veterans General Hospital, Taipei
Alexandra Hospital, Athens
General University Hospital of Patras Panagia i Voithia, Pátrai
Hospital Universitario 12 de Octubre, Madrid
Levine Cancer Institute, Charlotte
Charleston Oncology, Charleston
Emory University Winship Cancer Institute, Atlanta
Clinica Universidad de Navarra, Pamplona
Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque, Pessac
Ege University Faculty of Medicine, Izmir
Hospital Clinico Universitario de Salamanca, Salamanca
Hattiesburg Clinic Hematology/Oncology, Hattiesburg
Centre Hospitalier Universitaire de Nantes, Nantes
Gabrail Cancer Center, LLC, Dover
Fort Wayne Medical Oncology and Hematology, Fort Wayne
Theagenion Cancer Hospital of Thessaloniki, Thessaloniki
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy
Ondokuz Mayis Universitesi Tip Fakultesi, Samsun
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, Lille
Centre Hospitalier Lyon Sud, Pierre-Bénite
Baylor Charles A Sammons Cancer Center at Dallas, Dallas
Centre Hospitalier de Versailles - Hopital Andre Mignot, Le Chesnay
Centre Hospitalier Départemental les Oudairies, La Roche-sur-Yon
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie, Poitiers
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov, Petrozavodsk
Spitalul Clinic Municipal Filantropia Craiova, Craiova
Profesor Dr Ion Chiricuta Institut of Oncology, Cluj-Napoca
Clinic of professional pathology and hematology, Saratov
State Budget Educational Institution of High Professional Skills Samara State Medical University, Samara
Policlinica de Diagnostic Rapid, Brasov
SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko, Nizhny Novgorod
University of Chicago Medical Center - Multiple Myeloma Research Consortium, Chicago
Hackensack University Medical Center, Hackensack
Tom Baker Cancer Centre, Calgary
Cross Cancer Institute, Edmonton
Ottawa Hospital Research Institute, Ottawa
Princess Margaret Cancer Centre, Toronto
Hopital Maisonneuve-Rosemont, Montreal
Fakultni nemocnice Brno, Brno
Fakultni nemocnice Hradec Kralove, Hradec Králové
Fakultni nemocnice Ostrava, Ostrava-Poruba
Fakultni nemocnice Plzen, Pilsen
Vseobecna fakultni nemocnice v Praze, Prague
Nagoya City University Hospital, Nagoya
Toyohashi Municipal Hospital, Toyohashi
Tesshokai Kameda General Hospital, Kamogawa-shi
National Hospital Organization Kyushu Cancer Center, Fukuoka
Kyushu University Hospital, Fukuoka
Ogaki Municipal Hospital, Ogaki-shi
Gunma University Hospital, Maebashi
National Hospital Organization Shibukawa Medical Center, Shibukawa-shi
University Hospital Kyoto Prefectural University of Medicine, Kyoto
Niigata Cancer Center Hospital, Niigata
National Hospital Organization Okayama Medical Center, Okayama
Osaka University Hospital, Suita-shi
Saitama Medical Center, Kawagoe-shi
Tochigi Cancer Center, Utsunomiya
Tokushima Prefectural Central Hospital, Tokushima
Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku
Japanese Red Cross Medical Center, Shibuya-ku
InterHem, Bialystok
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie, Chorzów
Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli, Lublin
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu, Poznan
Instytut Hematologii i Transfuzjologii, Warsaw
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw
Spitalul Clinic Colentina, Bucharest
Fundeni Clinical Institute, Bucharest
Coltea Clinical Hospital, Bucharest
Bucharest Emergency University Hospital, Bucharest
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
The Catholic University of Korea Seoul St Marys Hospital, Seoul
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Clinic i Provincial de Barcelona, Barcelona
Hacettepe Universitesi Tip Fakultesi, Ankara
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara
St James University Hospital, Leeds
University College London Hospital, London
Christie Hospital, Manchester
Lead Sponsor
Amgen
INDUSTRY