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
-- 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
|SOURCE Millennium Pharmaceuticals, Inc.|
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