VELCADE(R) (Bortezomib) for Injection Combination Shows High Complete and Near Complete Response Rate in Preliminary Data From Phase III Front-Line Multiple Myeloma Trial
Sunday December 10, 4:45 pm ET
VELCADE dexamethasone combination shows greater than two-fold benefit over vincristine, adriamycin and dexamethasone therapy
ORLANDO, Fla., Dec. 10 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today reported that the Intergroupe Francophone du Myelome (IFM) cooperative group presented preliminary data from a Phase III clinical trial in newly diagnosed multiple myeloma (MM) patients treated with VELCADE® (bortezomib) for Injection in combination with dexamethasone as induction therapy prior to stem cell transplantation. Data showed that the VELCADE and dexamethasone combination achieved a complete and near complete response (CR/nCR) rate of 20 percent, greater than a two-fold improvement over the vincristine, adriamycin and dexamethasone triplet (VAD), a commonly used therapy in this treatment setting. The trial is part of a comprehensive registration-enabling Phase III program evaluating VELCADE in the treatment of newly diagnosed MM patients in the transplant and non- transplant settings. The preliminary results were reported at the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH), December 9-12, 2006, in Orlando, Fla.
"These preliminary data are the first to be reported from a randomized Phase III trial of VELCADE in newly diagnosed patients and represent an important step in building the evidence for the role of VELCADE in this treatment setting," said Jean-Luc Harousseau, M.D., of Hospital Hotel-Dieu, Nantes, France. "Achieving a high CR rate, as seen with VELCADE based induction therapy prior to stem cell transplantation, is important because it may lead to improved long-term outcomes for patients. We look forward to completing the trial."
VELCADE (Bortezomib) Dexamethasone Versus VAD as Induction Treatment Prior to Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma: An Interim Analysis of the IFM 2005-01 Randomized, Multicenter Phase III Trial (Abstract # 56)
The multicenter, randomized Phase III clinical trial was designed to compare VELCADE in combination with dexamethasone to VAD as induction treatment prior to stem cell transplantation in 480 newly diagnosed MM patients. The preliminary analysis presented at the conference included data from the first 161 eligible patients enrolled in the trial. The 79 patients in the VELCADE and dexamethasone arm were treated for four 21-day cycles of VELCADE at its standard dose and schedule of 1.3 mg/m2 on days 1, 4, 8 and 11, with oral dexamethasone at 40 mg/m2 on days one through four and days nine through 12 for cycles one and two and on days one through four for cycles three and four. The 82 patients on the VAD arm received four 28-day cycles of vincristine at 0.4 mg/m2 continuous infusion on days one through four, adriamycin at 9 mg/m2 continuous infusion for days one through four and oral dexamethasone at 40 mg/m2 on days one through four, days nine through 12 and days 17 to 20 for cycles one and two, and on days one and four for cycles three and four. Data presented were investigator-assessed responses using modified European Group for Blood and Marrow Transplantation (EBMT) criteria. Results presented by Professor Harousseau included:
- VELCADE and dexamethasone showed a CR/nCR rate of 20 percent compared to
a nine percent rate for VAD
- VELCADE and dexamethasone showed a CR and very good partial response
(VGPR) rate of 43 percent compared to a 26 percent rate for VAD
- VELCADE and dexamethasone showed an overall response rate (CR and
partial response) of 82 percent compared to a 67 percent rate for VAD
- VELCADE and dexamethasone was well tolerated; the most common adverse
events were nausea, constipation and anemia
The IFM group continues to enroll patients to achieve the target of 480 patients. Response data for the interim analysis are being determined by an independent data review committee. An early filing opportunity may be possible in 2007. |
