Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Multiple Myeloma
Interventions
DRUG

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."

Trial Locations (2)

90069

James R. Berenson M.D. Inc., West Hollywood

07601

John Theuer Cancer Center Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Oncotherapeutics

INDUSTRY