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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

t. After median follow up of 13.6 months, median progression-free survival and overall survival have not been reached. Side effects were manageable and included hematologic toxicity and peripheral neuropathy.

Safety and Efficacy of Lenalidomide, VELCADE and dexamethasone in Patients with Newly Diagnosed Multiple Myeloma: A Phase I/II Study (Abstract #8520)

This Phase I/II study of VcRD combination therapy was designed to determine the maximum tolerated dose (MTD) and efficacy in previously untreated MM patients. The preliminary analysis included 66 evaluable patients, who received VELCADE at 1.0 mg/m2 or 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day schedule. Patients also received lenalidomide at 15, 20 or 25 mg on days 1 through 14 and dexamethasone at 40 or 20 mg on the day of and day after each VELCADE dose. Patients were treated for up to eight cycles at four planned dose levels. Maximum planned dose was VELCADE 1.3 mg/m2, lenalidomide 25 mg and dexamethasone 20 mg. Response was assessed by modified EBMT criteria and International Myeloma Working Group criteria. Results were presented by Paul Richardson, M.D., Associate Professor of Medicine, Harvard Medical School; Clinical Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston and showed a CR rate of 35 percent at maximum planned dose and a 100 percent overall response rate (CR + partial response). Side effects were manageable and included lymphopenia, thrombocytopenia, hypophosphatemia and neutropenia. No grade 4 peripheral neuropathy was observed.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000
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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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