Millennium reports positive results from Phase III myeloma trial

As induction therapy prior to stem cell transplantation (SCT), the Velcade, thalidomide and dexamethasone (VcTD) arm demonstrated a complete remission (CR, including immunofixation positive and negative) rate of 36% compared to 9% in the TD arm (p<0.001). Following transplantation, the VcTD arm demonstrated a complete remission (CR, including immunofixation positive and negative) rate of 57% compared to 28% in the TD arm (p<0.001). Successful stem cell mobilization occurred in more than 90% of patients in both arms. Patients in the VcTD arm received Velcade at 1.3 mg/m(2) on days 1, 4, 8 and 11; dexamethasone at 40 mg each day of and after Velcade; thalidomide at 200 mg daily on a 21-day cycle for three cycles. Patients in the TD arm received dexamethasone at 40 mg on days 1 through 4 and 9 through 12 of every 21-day cycle and thalidomide up to 200 mg on a 21-day cycle for three cycles. The primary endpoint of the trial is CR to induction therapy and secondary endpoints include post-transplant CR, time-to-disease progression (TTP), event-free survival (EFS), overall survival (OS) and toxicity. VcTD was a well tolerated induction regimen with the incidence of grade two and grade three adverse events similar in each arm. Michele Cavo, principal investigator of the trial, said: "This Velcade based induction regimen achieved a fourfold increase in the complete remission rate. Complete remission is widely recognized as a predictor for long-term survival. These exciting results demonstrated that adding Velcade to the standard induction therapy prior to stem cell transplantation improves the response rate dramatically."