SUMMIT, New JerseyCelgene Corporation has announced preliminary efficacy results from a large, randomized trial of patients with newly diagnosed multiple myeloma showing that low-dose dexamethasone plus lenalidomide (Revlimid) has a significant survival advantage over lenalidomide plus higher standard-dose dexamethasone.
Safety results of the trial, showing a significantly reduced risk of adverse events, including venous thromboembolism, with the low-dose steroid regimen, were presented at the American Society of Hematology (ASH) 2006 annual meeting and reported in ONI last month (April 2007).
After the Eastern Cooperative Oncology Group (ECOG) reported the significant improvement in survival to the study's Data Monitoring Committee, the trial was closed early.
The primary objective of the trial, which was sponsored by the National Cancer Institute, was to determine if the low-dose steroid arm would have similar response rates and lower toxicity than the standard-dose arm. The trial randomized 445 patients to lenalidomide 25 mg/d plus either high-dose dexamethasone (40 mg on days 1-4, 9-12, and 17-20) or low-dose dexamethasone (40 mg on days 1, 8, 15, and 22).
The preliminary findings showed that patients in the study who received low-dose dexamethasone and lenalidomide had a 1-year survival of 96%, compared with 86% for patients treated with len-alidomide plus the standard-dose of dexamethasone. The full results of the data will be presented at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago in June.
Lenalidomide is currently FDA approved for use as a treatment in combination with standard-dose dexamethasone for patients with multiple myeloma who have received at least one prior therapy.
The only FDA approved regimen for induction therapy for myeloma is the combination of thalidomide (Thalomid) and dexamethasone, which achieves good response rates but with substantial toxic effects.