According to a phase III, multicenter, randomized, double-blind trial, the addition of Revlimid (lenalidomide) to dexamethasone improves responses, time to progression and survival when compared to dexamethasone alone in the treatment of relapsed or refractory multiple myeloma.

Revlimid is an oral immunomodulatory agent that is a thalidomide analogue. Revlimid provides anti-angiogenesis properties, and its full mechanism of action is still being evaluated.

Researchers recently provide results of the MM-009 study, which was a phase III trial. Patients were randomized to Revlimid/dexamethasone or to dexamethasone only. The trial included 341 evaluable patients who had relapsed or refractory multiple myeloma and had received at least one prior regimen. Patients were randomized to Revlimid (25 mg daily, days 1-21 every 28 days) plus high-dose dexamethasone (40 mg days 1-4, 9-12, 17-20 every 28 days; after cycle 5, days 1-4 only), or placebo plus high-dose dexamethasone.

• Overall response rates were 59.4% for patients treated with Revlimid/dexamethasone, compared to 21.1% for those treated with dexamethasone only (p<0.001).
• Median time to progression was 11.1 months for those treated with Revlimid/dexamethasone, compared to 4.7 months for those treated with dexamethasone only (p<0.0001).
• Median overall survival was 29.6 months for those treated with Revlimid/dexamethasone, compared with 20.2 months for those treated with dexamethasone only (p<0.0001).
• Grades III/IV toxicities were greater in the Revlimid arm: increased rates of neutropenia, anemia, atrial fibrillation, and thrombotic episodes.

The researchers concluded that the addition of Revlimid to dexamethasone improves response rates, time to disease progression and overall survival compared to dexamethasone only in relapsed/refractory multiple myeloma.

Reference: Weber D, Chen C, Niesvizky R, et al. Lenalidomide Plus High-Dose Dexamethasone Provides Improved Overall Survival Compared to High-Dose Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma (MM): Results of a North American Phase III Study (MM-009). Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. Atlanta, Ga. June 2006. Abstract # 7521.

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