511
Participants
Start Date
May 31, 2006
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2014
Bortezomib, Melphalan, Prednisone, Thalidomide
"Induction therapy:~9 courses with weekly VELCADE (4 doses) in combination with oral Melphalan 9 mg/m2,oral Prednisone 60 mg/m2 once daily on Days 1 to 4 of each course and Thalidomide 50 mg/day continuously. The dose of VELCADE is 1.3 mg/m2 administered as a bolus IV injection, on days 1, 8, 15, 22.~Maintenance therapy:~Thalidomide 50 mg/day continuously in combination with VELCADE 1.3 mg or maximum dose tolerated/m2/2 weeks. The maintenance will be initiated at the end of the 9th course and will be stopped after progression. The median expected duration of the maintenance treatment is approximately 2 years."
Bortezomib, Melphalan, Prednisone
Induction therapy: 9 courses with weekly VELCADE(4 doses) in combination with oral Melphalan 9 mg/m2 and oral Prednisone 60 mg/m2 once daily on Days 1 to 4 of each course. No maintenance therapy is scheduled
A.O.U. S. Giovanni Battista, Torino
Fondazione EMN Italy Onlus
OTHER