Champion 2012-002: A Phase 1/2, Multicenter, Single-arm, Nonrandomized, Open-label and Dose-escalation Study of Weekly Carfilzomib and Dexamethasone (Cd-qw) for Patients With Progressive Multiple Myeloma
Dr. Charles Kuzma
Men or women, 18 years or older, with multiple myeloma with relapsing or progressive disease. For additional criteria, call the Research Coordinator or visit the study weblink.
Onyx Therapeutics, Inc.
This is a Phase 1/2, multicenter, single-arm, nonrandomized, open-label and dose-escalation study of weekly carfilzomib and dexamethasone (Cd-qw) for patients with progressive multiple myeloma. The Phase 1 dose escalation portion will enroll patients into sequential dose-escalating cohorts consisting of 3 patients each to establish the maximum tolerated dose (MTD) of carfilzomib administered weekly as a 30 minute intravenous (IV) infusion with dexamethasone. The Phase 2 portion will enroll patients using the MTD established for carfilzomib from the Phase 1 portion of the study. Dexamethasone will be administered IV or PO at the same dose and schedule as used in the Phase 1 portion of the study.