38
Participants
Start Date
April 30, 2013
Primary Completion Date
December 31, 2018
Study Completion Date
December 31, 2018
Carfilzomib and Dexamethasone
"Phase 1: Carfilzomib will be administered at an escalating dose by cohort as 60-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. On Cycle 1 Days 1 and 2, carfilzomib will be given at 20 mg/m\^2. For all subsequent doses, carfilzomib will be administered at the dose assigned to the cohort (56, 70, or 88 mg/m\^2). Dexamethasone (8 mg IV or PO) will be administered prior to carfilzomib on Days 1, 2, 8, 9, 15, and 16.~Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: From Cycle 9 onward, carfilzomib and dexamethasone will be administered in the same fashion as during the previous treatment cycle, but only on days 1, 2, 15, and 16."
James R. Berenson M.D. Inc., West Hollywood
John Theuer Cancer Center Hackensack University Medical Center, Hackensack
Lead Sponsor
Collaborators (1)
Amgen
INDUSTRY
Oncotherapeutics
INDUSTRY