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news.Millennium Pharmaceuticals has initiated a randomized, multi-center, Phase II trial to evaluate the efficacy of Velcade for injection for the treatment of patients with newly diagnosed multiple myeloma.
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Millemmium says the trial, named Evolution, will combine Velcade with lenalidomide/ dexamethasone and also explore the incremental benefit of cyclophosphamide, an alkylating agent, which in previous studies has shown synergistic activity with Velcade.
“The objective of this trial is to evolve the treatment of multiple myeloma by combining these highly active therapies to induce early complete remission and improve long-term survival,” said Nancy Simonian, chief medical officer, Millennium.
The Evolution trial builds on positive results from previous studies of Velcade in combination with these agents. This trial is expected 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.