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Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients
Date:12/8/2008

preparation for and as consolidation after melphalan-based double ASCT in 460 patients with symptomatic MM. The median follow-up was 15 months.

The updated results, which were presented by Michele Cavo, M.D., Seragnoli Institute of Hematology and Medical Oncology, showed:

-- The two-year PFS was 90 percent in the VcTD arm, compared with 80 percent in the TD arm (p=0.009).

-- After three cycles of induction, CR/nCR rates were 32 percent in the VcTD arm, compared with 12 percent in the TD arm (p<0.001).

-- After the first ASCT, CR/nCR rates were 55 percent in the VcTD arm, compared with 32 percent in the TD arm (p<0.001).

-- After the first ASCT, VGPR or better rates were 76 percent in the VcTD arm, compared with 58 percent in the TD arm (p<0.001).

-- Serious adverse events were recorded in 15 percent of patients in the VcTD arm, compared with 12 percent of those in the TD arm.

Patients in the VcTD arm received 1.3 mg/m(2) of VELCADE on days 1, 4, 8 and 11; 200 mg of thalidomide daily and 40 mg of dexamethasone on days 1, 2, 4, 5, 8, 9, 11 and 12. Patients in the TD arm received 200 mg of thalidomide daily and 40 mg of dexamethasone on days 1 through 4 and 9 through 12 for three 21-day cycles.

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 new cases and over 45,000 deaths annually.

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. M
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SOURCE Millennium: The Takeda Oncology Company
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