Revlimid is an immunomodulatory drug (iMID) that is a derivative of thalidomide. Revlimid appears to have fewer associated toxicities than thalidomide and has received fast-track designation from the FDA for the treatment of both MDS and multiple myeloma. Revlimid has antiangiogeneic properties as well as numerous possible immune and biologic properties.
The first trial was a North American trial, referred to as MM-009, with data available from 352 patients. Patients with relapsed or refractory multiple myeloma were randomized to Revlimid plus HDD or placebo and HDD. Revlimid (25 mg) was given once daily on days 1-21 of a 28 day cycle, and HDD (40 mg) was given on days 1-4, 9-12 and 17-20 on a 28 day cycle. After four cycles of HDD, the schedule was reduced to days 1-4 every 28 days. Median time to progression was 60.1 weeks in patients treated with Revlimid, compared to 20.7 weeks for those treated with HDD only (p= 0.00000000000001). Best responses were achieved in 61% of patients in the Revlimid/HDD arm, compared to 22.8% in the HDD only arm. The second trial was an international trial, referred to as the MM-010 trial, with data available from 351 patients who were also randomized to the same regimen of Revlimid (25 mg) plus HDD or placebo/HDD. Median time to progression was in the Revlimid arm was 53.4 weeks, compared to only 20.6 weeks in the HDD only arm (p=0.0000000000001). Best responses were achieved in 58% of patients treated with Revlimid/HDD, compared with only 21.7% of patients treated with HDD only. Revlimid was associated with increased side effects in both trials, with grades ¾ toxicities being primarily hematologic: neutropenia, anemia and thrombocytopenia. Deep vein thrombosis and pulmonary embolism were slightly increased in the Revlimid arms.
The researchers concluded that the addition of Revlimid to HDD significantly improves time to cancer progression in relapsed and refractory multiple myeloma, with an acceptable toxicity profile. Revlimid will be available on an expanded access program in the United States and a named patient program in Europe.
Reference: Dimopoulos M, Weber D, et al. Phase III randomized, double-blind, placebo-controlled trials of lenalidomide-dexamethasone vs. dexamethasone for refractory and relapsed multiple myeloma. Proceedings from the 2005 annual meeting of the American Society of Clinical Oncology. Orlando, Florida. 2005. Presented at a scientific symposium Sunday, May 15, 2005.
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