According to results presented at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Revlimid® (lenalidomide) to dexamethasone improves anticancer responses and survival compared to dexamethasone only in patients with multiple myeloma who have received prior therapies.
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.
Revlimid is an agent that is referred to as an immunomodulatory agent. Revlimid fights cancer through several different biological mechanisms, many of which are still being evaluated. One action Revlimid uses against cancer is to prevent or reduce blood vessel growth to the cancer. This ultimately “starves” the cancer cells of nutrients and oxygen. Revlimid continues to be evaluated in various types of cancers in clinical trials.
Researchers recently conducted a multi-center, phase III trial (phase of trial prior to FDA review) referred to as the MM-009 study, to directly compare Revlimid plus the commonly used steroid dexamethasone to dexamethasone only in the treatment of multiple myeloma that has stopped responding to prior therapies.
- Overall anticancer response rates were achieved in nearly 60% of patients treated with Revlimid, compared to only 21% of patients treated with dexamethasone only.
- At 11 months, half of the patients treated with Revlimid had not yet experienced disease progression, compared to only 4.7 months for those treated with dexamethasone only.
- Overall survival was also significantly improved for patients treated with Revlimid: 29.6 months versus 20.2 months for those treated with dexamethasone only.
- Serious side effects were more common among patients treated with Revlimid, including low rates of immune cells, red blood cells, blood clots, and side effects involving the heart.
The researchers concluded that the addition of Revlimid to dexamethasone improves outcomes, including survival, compared to dexamethasone only in the treatment of recurrent/refractory multiple myeloma. Revlimid is not yet approved for the treatment of 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 42ndannual meeting of the American Society of Clinical Oncology. June 2006. Abstract #7521.
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