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New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients
Date:8/27/2008

s now can benefit from this VELCADE based therapy as have patients in the relapsed and refractory settings since 2003."

(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone

VISTA Trial Results

Patient responses were evaluated by the stringent European Group for Blood and Marrow Transplantation (EBMT) criteria:

-- A CR rate of 30 percent in the VcMP arm compared to 4 percent with MP (p<0.001)

-- VcMP demonstrated statistical significance in overall survival with a 39 percent reduction in risk of death (Hazard ratio= 0.61; p=0.008) with a follow-up of 16.3 months

-- The median treatment duration was 46 weeks for the VcMP arm compared to 39 weeks for the control arm and discontinuation due to adverse events was similar in both arms

Patients in the VcMP arm received VELCADE at 1.3 mg/m2 twice weekly in weeks one, two, four and five for four six-week cycles (eight doses per cycle), followed by once weekly on weeks one, two, four and five for up to five six-week cycles (four doses per cycle) in combination with melphalan at 9 mg/m2 and prednisone at 60 mg/m2 once daily on days 1 through 4 of each cycle for up to nine six-week cycles. For both groups, treatment continued for a maximum of 54 weeks.

"The tolerability of VcMP also was encouraging and side effects were generally manageable with appropriate supportive care and dose reduction as needed," commented Paul Richardson, M.D., Clinical Director of the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute and Senior Investigator on the study.

The safety profile of VELCADE in combination with MP is consistent with the known safety profiles of both VELCADE and MP. In VISTA, the most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46
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SOURCE Millennium
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