Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Multiple Myeloma
Interventions
DRUG

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."

DRUG

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

Trial Locations (1)

10126

A.O.U. S. Giovanni Battista, Torino

All Listed Sponsors
lead

Fondazione EMN Italy Onlus

OTHER

NCT01063179 - Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients | Biotech Hunter | Biotech Hunter