Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma
Approximately 155 evaluable subjects with relapsed multiple myeloma will be enrolled to evaluate the best overall response rate, safety and tolerability of carfilzomib in this phase 2 study. Patients must have previously received one to three prior therapies and were relapsed to the most recently received therapy.
|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 Multiple Myeloma|
- Best 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, best Overall Response Rate throughout the study, and Overall Survival [ Time Frame: 2 to 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 IV 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 IV 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.
Show 30 Study Locations
|Study Director:||Mai Le, MD||Onyx Pharmaceuticals|