Multiple Myeloma Trial Stopped Early Due to Significant Efficacy Advantage of Bortezomib

Millennium Pharmaceuticals, Inc, announced that the interim analysis results of the large, international phase III VISTA trial in patients with newly diagnosed multiple myeloma showed that VMP therapy (bortezomib [Velcade], melphalan [Alkeran], and prednisone) demonstrated a highly statistically significant improvement in all efficacy measures, including time-to-disease progression, complete remission rate, progression-free survival, and overall survival, compared to MP (melphalan and prednisone) alone. Based on the recommendation of an independent data monitoring committee after a planned interim analysis, the control arm of the trial was stopped early to allow patients still being treated with MP to have bortezomib added to their therapy.

"These results position Velcade-based therapy as a new standard of care for newly diagnosed multiple myeloma patients," said Paul Richardson, MD, associate professor of medicine, Harvard Medical School; clinical director, Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute Boston; and a lead investigator of the VISTA trial. "The combination of Velcade with melphalan and prednisone surpassed all efficacy endpoints, including time-to-disease progression, complete remission rate, progression-free survival, and overall survival, and did so much earlier than expected. We are excited at the possibility this new therapy could be available to our patients sooner."