Calgene Corporation

Phase 3 multiple myeloma trial with thalidomide reaches prespecified interim endpoint

Published in FDA Law Weekly, February 9th, 2006

Celgene Corporation (CELG) announced that an external independent data monitoring committee analysis of the multicentered, randomized, placebo-controlled phase 3 study of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the prespecified p<0.0015 value for stopping the trial.

The committee found time to disease progression, the primary endpoint of this phase 3 trial, of 75.7 weeks versus 27.9 weeks (p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3 weeks (p=0.0003) in patients receiving thalomid plus dexamethasone compared to patients receiving dexamethasone...

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Source: FDA Law Weekly (2006-02-09)

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