期刊
BLOOD
卷 121, 期 11, 页码 1961-1967出版社
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2012-08-450742
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资金
- Celgene Corporation
- Dana-Farber Cancer Institute
- John Theuer Cancer Center-Hackensack University Medical Center
- H. Lee Moffitt Cancer and Research Institute
- Massachusetts General Hospital
- Mayo Clinic Arizona
- Mayo Clinic Minnesota
- Roswell Park Cancer Institute
- Ohio State University-James Cancer Hospital
- University of Michigan Comprehensive Cancer Center
- Washington University-Siteman Cancer Center
- St Vincent's Comprehensive Cancer Center
- University of Pittsburgh Cancer Institute
- Emory University
- Princess Margaret Hospital-UHN
- Cross Cancer Center
- University of Calgary-Tom Baker Cancer Center
- Vancouver General Hospital
- Diamond Health Care Centre
- Royal Victoria Hospital McGill University
- Multiple Myeloma Research Consortium
This phase 1 dose-escalation study determined the maximum tolerated dose (MTD) of oral pomalidomide (4 dose levels) administered on days 1 to 21 of each 28-day cycle in patients with relapsed and refractory multiple myeloma (RRMM). After four cycles, patients who progressed or had not achieved minimal response (serum and urine M-protein reduction of >= 25% and >= 50%) could receive dexamethasone 40 mg per week. Safety and efficacy were evaluated. Thirty-eight patients who had received both bortezomib and lenalidomide (median 6 prior therapies) were enrolled; 63% were refractory to both lenalidomide and bortezomib. There were four dose-limiting toxicities (grade 4 neutropenia) at 5 mg per day and so the MTD was 4 mg per day. Rates of peripheral neuropathy and venous thromboembolism were low (<= 5%). Among the 38 patients enrolled (including 22 with added dexamethasone), 42% achieved minimal response or better, 21% achieved partial response or better, and 3% achieved complete response. Median duration of response, progression-free survival, and overall survival were 4.6, 4.6, and 18.3 months, respectively. Pomalidomide 4 mg per day on days 1 to 21 of each 28-day cycle, with or without dexamethasone (40 mg/week), has encouraging activity with manageable toxicity in RRMM, including those refractory to both lenalidomide and bortezomib.
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