Millennium presents Ph I Velcade trial results

Millennium Pharmaceuticals, a US subsidiary of Japan's leading drugmaker Takeda, presented Phase I results from a Phase I/II study of its Velcade (bortezomib), plus dexamethasone, cyclophosphamide and lenalidomide in patients with previously-untreated multiple myeloma, at the annual meeting of the American Society of Hematology in San Francisco.

In the randomized, multi-center EVOLUTION trial, the maximum tolerated dose of cyclophosphamide was not reached, but all patients had a partial response or better, with 36% of subjects achieving a complete response. The overall rate of serious adverse events was 40%, with the most common being constipation (64%), fatigue (60%) and nausea (52%).

The primary endpoints of the ongoing Phase II portion of the trial are complete response and very good partial response rates, while the secondary endpoints include progression-free survival, overall survival, safety and tolerability.