Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
250 evaluable subjects with relapsed and refractory multiple myeloma will be enrolled to evaluate the overall response rate and safety and tolerability of carfilzomib in this phase 2 study. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma|
- Overall Response Rate [ Time Frame: 2 to 12 months ] [ Designated as safety issue: No ]
- Safety and Tolerability, Clinical Benefit Response, Time to Progression, Duration of Response, Progression Free Survival, and Overall Survival [ Time Frame: 2 to 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
IV push twice weekly for three weeks followed by 12 days of rest. 28 days = 1 cycle. A maximum of 12 cycles will be administered.
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