An analysis of clinical trials assessing the efficacy and safety of single-agent thalidomide in patients with relapsed or refractory multiple myeloma

Abstract

Given that the efficacy/safety of thalidomide for relapsed or refractory multiple myeloma have not been well characterized in a randomized, controlled setting, an analysis of larger, single-agent trials was conducted. Nine trials met the following inclusion criteria: primary population of multiple myeloma; all patients relapsed or refractory; single-agent thalidomide; and sample size > or =50. At median doses of 200 - 800 mg per day, the pooled overall response rate (ORR) was 28.2% (95% CI: 22.6 - 33.7%), including a complete response (CR) rate of 1.6% (95% CI: 0.3 - 2.9%) and partial response rate of 26.0% (95% CI: 20.1 - 32.0%). Response was typically based on M-protein reduction alone. Pe..