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CC-4047 (Actimid) 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. |
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