Phase I study of an immunomodulatory thalidomide analog, CC-4047, in relapsed or refractory multiple myeloma.

摘要: Purpose To assess the safety, efficacy, and immunomodulatory effects of CC-4047 (Actimid; Celgene, San Diego, CA) in patients with relapsed or refractory myeloma. Patients Methods Twenty-four were treated a dose-escalating regimen oral CC-4047. Clinical responses adverse identified, peripheral T-cell subsets, serum cytokines, proangiogenic factors evaluated. Results was tolerated no serious nonhematologic events. All eligible for analysis. Toxicity criteria during initial 4 weeks study used to define maximum-tolerated dose (MTD). During this period, one patient withdrew deep vein thrombosis (DVT) probably caused by an undiagnosed primary melanoma lymphadenopathy groin, because progressive disease (PD), three discontinued neutropenia. Nineteen 24 continued on treatment beyond PD development se...