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Velcade Is Effective in Multiple Myeloma Trials


Posted on 2006-12-12 08:20:00



Millennium Pharmaceuticals, Inc. today reported the presentation of results of several clinical trials of Velcade (bortezomib) for Injection in combination with a variety of agents, including Doxil (pegylated liposomol doxorubicin) and dexamethasone, for the treatment of newly diagnosed multiple myeloma (MM) patients. Studies showed Velcade combination therapy produced very good partial response and complete response (VGPR/CR) rates as high as 53 percent as induction therapy, which improved to 79 percent following autologous stem cell transplantation (ASCT). In a study of Velcade in combination with dexamethasone, the one-year survival rate was 92 percent after a median follow up of 24 months.

"Evidence continues to build that Velcade based regimens provide high VGPR/CR rates in front-line patients as induction therapy prior to stem cell transplantation," said Nancy Simonian, M.D., Senior Vice President and Chief Medical Officer, Millennium. "With these high CR rates, we believe we are starting to see the benefit of Velcade on improved post-transplant outcomes."

The long-term follow up of a Phase II clinical trial evaluated Velcade in combination with dexamethasone in 48 evaluable newly diagnosed MM patients. Patients with measurable disease received Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11 of a three-week cycle for up to six cycles. Oral dexamethasone at 40 mg was added to the treatment regimen on the day of and day after Velcade for patients not achieving partial response (PR) after two cycles or for patients not achieving a CR after four cycles. Responses were assessed using modified European Group for Blood and Marrow Transplantation (EBMT) criteria.