Researchers recently reported promising results from a phase III clinical trial of Revlimid® (lenalidomide) plus dexamethasone for the treatment of multiple myeloma. These results were presented at the 47th annual meeting of the American Society of Hematology (ASH) in Atlanta Georgia on December 11, 2005.
Multiple myeloma is a cancer of the blood that affects the plasma cells. Plasma cells are an important part of the immune system; they produce antibodies to help fight infection and disease. Multiple Myeloma is characterized by an excess production of abnormal plasma cells. Symptoms include increased risk of bacterial infections and impaired immune responses. Myeloma may also damage the kidneys and cause osteoporosis, anemia, and an elevated blood calcium level. Although multiple myeloma is not curable, it can be treated to allow patients to live longer, healthier lives.
Revlimid is a derivative of thalidomide, which is a very active agent for the treatment of multiple myeloma. Thalidomide, however, has serious side effects. Revlimid is reported to have less toxicity than thalidomide, though it retains anti-myeloma effects. Revlimid prevents the growth of arteries and capillaries that carry nutrients to cancer cells. The deprivation of nutrients to cancer cells halts the progression and growth of cancer cells.
Two large clinical trials were recently conducted to compare treatment with Revlimid and dexamethasone to treatment with dexamethasone alone. The first, MM-009 trial, was conducted in North America and enrolled 340 patients with refractory multiple myeloma (myeloma that is not responding to treatment). Half the patients were treated with Revlimid and dexamethasone and half were treated with dexamethasone alone.
After more than 15 months of follow-up, outcomes were significantly better in the patients treated with Revlimid and dexamethasone. A reduction in detectable myeloma occurred in 51% of patients treated with Revlimid and dexamethasone and in 23% of patients treated with dexamethasone alone. Patients treated with Revlimid and dexamethasone also had longer periods without a worsening of their myeloma than patients treated with dexamethasone alone.
A second clinical trial (the MM-010 trial) enrolled 351 patients with relapsed or refractory multiple myeloma. Updated results from this trial were presented at ASH. Thirty-four percent of the patients had received thalidomide, and 59% had failed an autologous stem cell transplant. As in the previous trial, patients were randomly assigned to receive either Revlimid and dexamethasone or dexamethasone alone.
A reduction in detectable myeloma occurred in 57% of patients treated with Revlimid and dexamethasone and in 24% of patients treated with dexamethasone alone. Myeloma worsened after a median of 11 months in patients treated with Revlimid and dexamethasone and after five months in patients treated with dexamethasone alone. Toxic effects of treatment among patients receiving Revlimid and dexamethasone included neuropathy (33%) and deep vein thrombosis (8%).
These studies suggest that Revlimid has anti-myeloma activity with less toxicity than thalidomide.
Reference: Dimopoulos MA, Spenser A, Attal M, et al. Study of lenalidomide plus dexamethasone versus dexamethasone alone in relapsed or refractory multiple myeloma (MM): results of a phase 3 study (MM010). Blood. 2005;106:106, abstract number 6.
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