According to a recent presentation at the annual meeting of the American Society of Clinical Oncology, Revlimid® in addition to the drug dexamethasone significantly delays the time to cancer progression in patients who have previously been treated for multiple myeloma.
Multiple myeloma is a cancer of the blood, which affects the plasma cells. Plasma cells are an important part of the immune system that produce antibodies to help fight infection and disease. Multiple Myeloma is characterized by an excess production of abnormal plasma cells, which can result in symptoms such as increased risk for bacterial infections or impaired immune responses. Other effects of myeloma may include damage to the kidneys, osteoporosis, anemia and an elevated blood calcium level. Although multiple myeloma is not curable, it can be treated, allowing patients to live longer, healthier lives. Treatment options for multiple myeloma include watchful waiting, chemotherapy, radiation, and, in some cases, stem cell transplantation. Revlimid, a derivative of thalidomide, is a new drug that is considered to be an immunomodulatory drug (iMID). Immunomodulatory drugs work by either modifying or regulating the immune system. They appear to have anti-cancer and anti-inflammatory effects and are the focus of intense study.
Two large studies were conducted to evaluate the potential benefit of adding Revlimid to dexamethasone (a commonly used steroid for treatment of multiple myeloma) for the treatment of multiple myeloma that has recurred after treatment. The first trial was conducted in North America and included 352 patients who were treated with either Revlimid plus dexamethasone or a placebo (inactive substitute) with dexamethasone. Results of this trial revealed that the average time to cancer progression was 60.1 weeks among the patients treated with Revlimid, compared to 20.7 weeks for those treated with dexamethasone alone. Best responses were achieved in 61% of patients in the Revlimid/dexamethasone group, compared to 22.8% among the dexamethasone alone treatment group.
The second trial, which was performed internationally, included 351 patients who were treated with the same regimens. Results of this trial showed that the average time to cancer progression was 53.4 weeks for the Revlimid treatment group, compared to 20.6 weeks in the dexamethasone group. Best response rates were achieved in 58% of patients treated with Revlimid/dexamethasone, compared to only 21.7% of patients treated with dexamethasone alone.
Side effects were increased with the addition of Revlimid, which primarily resulted in a drop in blood counts. Blood clots were also slightly more frequent among the patients treated with Revlimid.
Researchers concluded that the addition of Revlimid to dexamethasone significantly improves the time to cancer progression in recurrent or resistant multiple myeloma, and is generally well tolerated.
Reference: Dimopoulous 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 41st annual meeting of the American Society of Clinical Oncology. Orlando FL. 2005.
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