Bendamustine, Bortezomib (Velcade ®) and Prednisone (BVP) in Patients Newly Diagnosed Multiple Myeloma
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy
(in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone
(BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or
unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous
transplant receive four cycles of BVP, hematopoietic stem cell collection and administration
of two cycles BVP over followed by autologous transplant.
In addition to the overall response rates, will also be analyzed time to progression (TTP),
progression-free survival (PFS) and overall survival.
Finally, the results will be compared with BVP with those obtained in 120 patients included
in our protocol VMP GEM10MAS65.
Patients will be evaluated at scheduled visits up to 3 periods of study:
pretreatment, treatment and monitoring.