Celgene Corporation said that the Southwest Oncology Group has permanently closed enrollment in a phase III trial comparing dexamethasone with dexamethasone plus Revlimid for patients newly diagnosed with multiple myeloma.
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Southwest Oncology Group (SWOG) added that study participants would be given the choice of switching to Revlimid with dexamethasone. According to SWOG, the 198 patients enrolled in the trial, prior to the closure, are sufficient to provide data analysis and evaluate the primary endpoint of progression-free survival in the two arms of the trial. Data analysis is ongoing and results will be presented and released in the usual fashion.
Revlimid (lenalidomide) is already approved by the FDA for use as a treatment in combination with standard-dose dexamethasone for patients with multiple myeloma who have received at least one prior therapy. Revlimid is also approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
New Jersey-based Celgene said that Revlimid recently received a positive opinion from the European Medicines Agency for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.
Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow, replacing normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.