A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
In Multiple Myeloma (MM) patients, the conventional treatment is the oral combination
melphalan and prednisone (MP). thalidomide has been widely used in myeloma, it has been
proved clinical effective in refractory myeloma patients, it acts sinergistically in
association with dexamethasone. In newly diagnosed patients, the combination oral MP plus
thalidomide increased the partial and complete response rate.Bortezomib represents a novel
class of anti-cancer drugs, it is active in patient with multiple myeloma who are refractory
to conventional chemotherapy. In a preliminary report, the combination of VELCADE and
Thalidomide induced a remarkable 60% PR rate in advanced refractory myeloma patients. This
study will evaluate the safety and the efficacy of the association of Melphalan/
Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory
myeloma patients. This association might further increase the response rate achieved by the
standard oral MP regimen.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
SAFETY AND EFFICACY
MARIO BOCCADORO, MD
Principal Investigator
DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY
Italy: Ministry of Health
X05141
NCT00358020
November 2004
December 2008
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