HOUSTON - Pairing a new thalidomide derivative with a steroid slows progress of multiple myeloma, an incurable bone marrow cancer, and prolongs the lives of patients who have relapsed from previous treatment, researchers report in the Nov. 22 New England Journal of Medicine.
In the study conducted at 44 centers in the United States and Canada, 353 patients with myeloma received either a combination of lenalidomide (Revlimid(r)) and the steroid dexamethasone or dexamethasone plus a placebo.
"Those taking the lenalidomide combination had a median time to disease progression of 11.1 months compared with 4.7 months in the placebo-dexamethasone group and an improved median overall survival time of 29.6 months compared with 20.2 months," says lead author Donna Weber, M.D., associate professor in the Department of Lymphoma and Myeloma at The University of Texas M. D. Anderson Cancer Center.
The results were impressive enough that in December of 2005 an independent interim data analysis resulted in the trial being halted early so those on placebo-dexamethasone could also benefit from the addition of lenalidomide.
The collaborative study by North American Multiple Myeloma Study Investigators, and an international trial also reported in the New England Journal of Medicine, led to the approval of lenalidomide and dexamethasone for previously treated patients by the U.S. Food and Drug Administration in 2006.
"These trials highlight how large-scale cooperation in a team effort by myeloma investigators can quickly confirm benefits and introduce new active agents for patients with this disease," Weber says. "We also owe a debt to the willing patients who participated in this study."
Multiple myeloma is caused by formation of abnormal plasma cells, a type of white blood cell, in the bone marrow. These cells multiply rapidly, crowding out normal red and white blood cells and platelets. Tumors starting in the bone marro
|Contact: Scott Merville|
University of Texas M. D. Anderson Cancer Center