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Revlimid (lenalidomide) survival data evaluated in previously treated multiple myeloma

07-27-2006

Celgene International Sarl announced clinical data from two multicentered, randomized, double-blind and placebo-controlled Phase III pivotal studies evaluating lenalidomide plus dexamethasone in previously treated patients with multiple myeloma.

The updated clinical data from the pivotal International Phase III trial (MM-010) reported overall survival (p=.03) in addition to median time to disease progression (p<.0001). As of June 2006, median overall survival in the International trial in patients treated with lenalidomide plus dexamethasone has not been reached as compared to 20.6 months with dexamethasone plus placebo. The clinical data from the pivotal North American Phase III trial (MM-009) reported overall survival (p=.0001) in addition to median time to disease progression (p<.0001).

Data from the international study reported the median overall survival in patients treated with lenalidomide plus dexamethasone have not been reached compared with 20.6 months for dexamethasone plus placebo (p=.03). The median time-to-disease progression with lenalidomide plus dexamethasone was 11 months, compared with 5 months for dexamethasone plus placebo (p<.001).

Overall response rate with lenalidomide plus dexamethasone was 59 percent compared with 24 percent for dexamethasone plus placebo (p<.001). Complete response (CR) rate (based on EBMT criteria) with lenalidomide plus dexamethasone was 15 percent, compared with 3.4 percent for dexamethasone plus placebo (p<.001). The most common side effects were constipation, diarrhea and neutropenia.

Both trials were randomized, double blind, placebo-controlled, phase III studies using lenalidomide plus dexamethasone versus dexamethasone plus placebo in previously treated patients with multiple myeloma.

Celgene is a global pharmaceutical company.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2006, Biotech Business Week via NewsRx.com.

Related Diseases: Multiple Myeloma

Related Keywords: Complete Remission (CR), Dexamethasone, Lenalidomide (Revlimid)

Related Glossary Terms: Clinical Trial, MM

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