Millennium Begins Phase II Trial of Velcade

August 15, 2007

Millennium Pharmaceuticals announced the initiation of a randomized, multicenter, Phase II trial to evaluate the efficacy of combining Velcade for injection, lenalidomide/dexamethasone and cyclophosphamide in the frontline multiple myeloma setting.

The EVOLUTION trial will combine Velcade (bortezomib) and lenalidomide/dexamethasone and also explore the incremental benefit of cyclophosphamide, an alkylating agent, Millennium said.

The EVOLUTION trial builds on positive results from previous studies of Velcade in combination with these agents, showing some of the highest reported complete remission rates, the company added.

This company expects to enroll approximately 100 patients, who will be randomized to either Velcade, lenalidomide/dexamethasone, or Velcade, lenalidomide/dexamethasone and cyclophosphamide.

The primary endpoint of the trial is complete response and very good partial response rates with secondary endpoints, including duration of response, overall survival, safety and tolerability, the company added.