Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multiple Myeloma
Sunday December 9, 8:43 pm ET
- VELCADE, thalidomide and dexamethasone improved pre - and post-stem cell transplantation results compared to thalidomide and dexamethasone -
ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) reported the presentation of results from an interim analysis of the first 256 patients evaluated in a multi-center, randomized Phase III clinical trial. This study compared VELCADE, thalidomide and dexamethasone (VcTD) to thalidomide and dexamethasone (TD) alone, currently the most commonly used U.S. regimen for patients with previously untreated multiple myeloma (MM). The trial was conducted by the Italian Myeloma Network (GIMEMA) cooperative group and selected for an oral presentation at the American Society of Hematology (ASH) 49th Annual Meeting in Atlanta, Ga., December 8- 11, 2007.
"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," said Professor Michele Cavo, M.D., Seragnoli Institute of Hematology, University of Bologna and Principal Investigator of the trial. "These exciting results demonstrated that adding VELCADE to the standard induction therapy prior to stem cell transplantation improves the response rate dramatically."
Results from the large clinical trial were presented by Professor Cavo:
-- As induction therapy prior to stem cell transplantation (SCT), the VcTD arm demonstrated a complete remission (CR, including immunofixation positive and negative) rate of 36 percent compared to 9 percent 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 percent compared to 28 percent in the TD arm (p<0.001)
-- Successful stem cell mobilization occurred in more than 90 percent of patients in both arms
"We are excited to see that the VELCADE combination continues to improve the complete remission rates of commonly used regimens to deliver significantly better results for patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "This is one of the three Phase III front-line multiple myeloma trials presented at ASH that clearly establishes VELCADE as a leading therapy for patients with previously untreated multiple myeloma."
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. |
