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Results of a multicenter, randomized, double-blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma
Cancer, 10/30/09

Eisen T et al. – The results of an international, multicenter, randomized, double-blind, controlled study assessing the efficacy and safety of lenalidomide treatment in patients with refractory stage IV metastatic malignant melanoma are reported. This study showed that treatment with lenalidomide (25 mg/d) has a manageable safety profile in patients with previously treated metastatic malignant melanoma but no benefit in tumor response, time to progression, or overall survival in these patients.

Methods

Compared treatment with lenalidomide (25 mg/d on Days 1-21 of a 28-day cycle) to placebo in 306 patients with metastatic malignant melanoma
Treatment was continued until progression of disease or unacceptable toxicity

Results

No significant differences between lenalidomide and placebo in overall survival (median 5.9 months vs 7.4 months, respectively, time to progression (median 3.0 months vs 2.1 months), or Response Evaluation Criteria in Solid Tumors tumor response (5.3% vs 5.8%)
None of patients given placebo discontinued treatment because of treatment-related adverse events, compared with 4.6% of those treated with lenalidomide
Treatment-related myelosuppression observed in 2.0% of patients treated with placebo and 7.3% of patients treated with lenalidomide