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Velcade (bortezomib) for Injection Based Induction Therapy,Delivered High Post-Transplant Complete Remission Rate, a Critical,Marker for Increased Overall Survival

DE as an important therapy for front-line patients."

The multi-center, randomized Phase III trial is being conducted by the IFM cooperative group. The trial was designed to compare VELCADE in combination with dexamethasone to VAD as induction therapy prior to SCT in 480 newly diagnosed MM patients. The presentation during IMW included new data from 161 patients who received induction therapy, of which 137 patients received SCT. Results presented by Dr. Harousseau showed:

     * As induction therapy prior to SCT, the VELCADE based therapy showed

       a CR rate of 20 percent compared to 7 percent for VAD.

     * Following SCT, the VELCADE based therapy demonstrated a CR rate of

       43 percent and a very good partial response + CR (VGPR + CR) rate of 75

       percent.  VAD showed a CR rate of 28 percent and a VGPR + CR

       rate of 46 percent following SCT.

     * The VELCADE based therapy was well tolerated; the most common adverse

       events included neurologic toxicities, fever/infection and neutropenia.

Patients on the VELCADE based therapy received four standard cycles of VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle. Patients also received dexamethasone at 40 mg on days 1 through 4 during cycles one through four and on days 9 through 12 during cycles one and two only. Patients on VAD were treated for four cycles with vincristine at 0.4 mg/m2 on days 1 through 4; adriamycin at 9 mg/m2 on days 1 through 4; and dexamethasone 40 mg on days 1 through 4, days 9 through 12 during cycles one through four and on days 17 through 20 during cycles one and two only. Some patients received consolidation therapy. Response was assessed by the European Group for Blood and Marrow Transplant criteria.

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