315
Participants
Start Date
September 30, 2010
Primary Completion Date
July 31, 2014
Study Completion Date
September 30, 2015
Carfilzomib
20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).
Best Supportive Care
"Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."
Nedlands
Perth
Linz
Salzburg
Vienna
Arlon
Bruges
Brussels
Roeselare
Brno
Hradec Kralov
Olomouc
Prague
Lyon
Nantes
Nîmes
Dresden
Giessen
Koblenz
Mainz
München
Ulm
Athens
Rio Patras
Budapest
Debrecen
Győr
Gyula
Kaposvár
Pécs
Szeged
Haifa
Jerusalem
Kfar Saba
Nahariva
Petah Tikva
Sheba
Ancona
Novara
Roma
Torino
North Shore
Gdansk
Lodz
Piła
Torum
Warsaw
Wroclaw
Zamość
Moscow
Saint Petersburg
Belgrade
Niš
Bratislava
Incheon
Seoul
Barcelona
Guipuzcoa
Murcia
Salamanca
Seville
Valencia
Zaragoza
Uppsala
Hampshire
London
Manchester
Oxford
Lead Sponsor
Amgen
INDUSTRY