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Clinical Trial Details

Study Title: 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
Study Type: Interventional
Study Condition: Multiple Myeloma
Investigator: Dr. Charles Kuzma
Phone: (910) 715-3500
Research Coordinator: Pam Mason
Phone: (910) 715-2200
Eligibility Criteria: 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.
Sponsor Organization: Onyx Therapeutics, Inc.
Study Rationale:
Study Purpose: 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.
Study Link:
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