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Publication of Clinical Results Underscores VELCADE(R) (Bortezomib) For Injection Based Therapy As a Standard of Care In Newly Diagnosed Multiple Myeloma Patients
Date:3/13/2008

d of care in this patient setting."

The study was pre-published online in the journal, Haematologica. Data from the 60 patient Phase I/II trial conducted by the PETHEMA Foundation in Spain were evaluated by the stringent European Group for Blood and Marrow Transplantation (EBMT) criteria and results are as follows:

-- Results showed an immunofixation-negative CR rate of 32 percent and an

overall response rate (ORR) of 89 percent with VcMP.

-- The overall survival rate at 38 months was 85 percent with VcMP

compared to the 38 percent historical control with melphalan and

prednisone (MP) (p<0.0001). The median overall survival for VcMP has

not been reached compared to 26 months among the historical control

with MP.

-- The median time-to-disease progression (TTP) with VcMP of 27.2 months

compared to 20 months for the historical control with MP (p=0.001).

-- The median event-free survival (EFS) with VcMP of 25 months compared to

15 months for the historical control with MP (p=0.001).

-- VcMP was well tolerated in this elderly patient population (median age

of 75) with patients on therapy for more than nine months. The safety

profile was predictable and manageable.

Patients received VELCADE at 1.3 mg/m2 (n=54) or 1.0 mg/m2 (n=6) twice weekly in weeks one, two, four and five for four six-week cycles (eight doses per cycle), followed by once weekly in weeks one, two, three and four for five, five-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. Treatment continued for a maximum of 49 weeks (52 vials) with a median number of 39 weeks (42 vials) reported in the trial. The safety profile of VcMP was as expected based on the known safety profile of each of the individual agents in the combination, including thrombocytopenia, neutropenia and peripher
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SOURCE Millennium Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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