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Phase 3 Trial of Thalidomide in Myeloma Reaches Pre-Specified Interim Endpoint

SUMMIT, N.J., Jan. 9 /PRNewswire-FirstCall/ -- Celgene Corporation (NASDAQ:CELG) announced that an external Independent Data Monitoring Committee analysis of the multi-centered, randomized, placebo-controlled phase III study of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the pre-specified p Treatment assignments for patients currently on the trials will be unblinded and those currently not on THALOMID will have the opportunity to add THALOMID to their dexamethasone regimen.

The thalidomide phase III special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 270 patients were randomized to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multi-centered clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.

Patients treated with thalidomide and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone alone. These adverse drug events included insomnia, tremors, dizziness, peripheral neuropathy and constipation. Grade 3 or 4 adverse events reported included deep vein thrombosis (DVT) occurred in 10.3% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone, and pulmonary embolism (PE) occurred in 5.6% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone.

Source: Celegene Corporation

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