Another potent IMiD, CC-4047, has been evaluated in a phase I study.1 Twenty-four patients with refractory/relapsed MM were treated with dose-escalated CC-4047 (1, 2, 5, and 10 mg daily). Toxicity criteria at 28 days were used to define the MTD. One patient withdrew because of VTD, 1 because of progressive disease, and 3 because of neutropenia. Three additional patients developed VTD within 1 year of therapy. The established MTD was 2 mg daily. Some response (> 25% reduction in circulating myeloma protein) was observed in 67% of patients. Thirteen patients (54%) experienced > 50% reduction in paraprotein, and 4 patients (17%) achieved CR. CC-4047 therapy was associated with significantly increased serum IL-2 receptor and IL-12 levels, which is consistent with activation of T cells and monocytes and macrophages. CC-4047 appears to be another promising agent with a role for further studies as an immunostimulatory modality of treatment for patients with relapsed/refractory MM. However, the incidence of VTD needs to be kept in mind, with the possible role of acetylsalicylic acid in these patients as well.
1. Schey SA, Fields P, Bartlett JB, et al. Phase I study of an immunomodulatory thalidomide analog, CC-4047, in relapsed or refractory multiple myeloma. J Clin Oncol. 2004;22:3269-3276.
