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Velcade post-approval studies

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Millennium will conduct a Phase IV study comparing a combination of Velcade and high-dose dexamethasone to the two drugs alone in previously untreated multiple myeloma patients. The study, a condition of the agent's May 13 accelerated approval, is slated to begin in 2005 and could result in a first-line indication. The firm also will complete a Phase III trial evaluating survival, response rate and time to progression for Velcade versus high-dose dexamethasone in relapsed, refractory MM patients. Peripheral neuropathy frequency, severity and reversibility will be evaluated in the two trials and in an open-label extension study...
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