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Multiple Clinical Trials of VELCADE(R) (Bortezomib) for Injection Based Therapies Demonstrate High Complete Remission Rates in Patients with Newly Diagnosed Multiple Myeloma
Date:5/31/2008

.3 mg/m2 on days 1, 4, 8 and 11, and dexamethasone at 40 mg on days 1 through 4, 9 through 12, and 17 through 20 of a 28-day schedule. A total of four cycles was planned with a goal of proceeding on to stem cell transplant (SCT). Results were presented by Craig Reeder, M.D., Assistant Professor of Medicine, Mayo Clinic College of Medicine, and showed a CR rate of 46 percent prior to transplant, a CR rate of 72 percent post-transplant and an overall response rate (partial response or better) of 95 percent. Side effects included thrombocytopenia, neutropenia, hyperglycemia and peripheral neuropathy.

VELCADE, Pegylated-Lyposomal-Doxorubicin and dexamethasone (PAD or VcDD) as Induction Therapy Prior to Reduced Intensity ASCT Followed by Lenalidomide and Prednisone (LP) as Consolidation and Lenalidomide Alone as Maintenance (Abstract #8518)

This study of PAD (VcDD) was designed to evaluate the VELCADE combination as induction therapy prior to SCT in patients with newly diagnosed multiple myeloma. The results showed the status of 86 evaluable patients who received VELCADE at 1.3 mg/m2 on days 1, 4, 8, 11, DOXIL at 30 mg/m2 on day 4 and dexamethasone at 40 mg on days 1 through 4, 8 through 11, 15 through 18 for one cycle and on days 1 through 4 for cycles two through four. Cyclophosphamide at 3 g/m2 and G-CSF were used to harvest stem cells. Patients were then conditioned with two courses of melphalan at 100 mg/m2 (MEL100). Following SCT, patients received lenalidomide at 25 mg/day on days 1 through 21 plus prednisone at 50 mg every other day for four, 28-day LP cycles. This was followed by lenalidomide alone at 10 mg/day on days 1 through 21 every 28 days. Results were presented by Antonio Palumbo, M.D., Chief of the Myeloma Unit; Department of Hematology, University of Torino and showed 94 percent of patients achieved at least a partial response, including a CR rate of 21 percent after four cycles of VcDD. Post transplant, the CR rate increased to 59 percen
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SOURCE Millennium Pharmaceuticals, Inc.
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10. Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
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