Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients
|Multiple Myeloma||Drug: Bortezomib, Melphalan, Prednisone, Thalidomide Drug: Bortezomib, Melphalan, Prednisone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS|
- Determine whether the V-MPT combination improves progression free survival (PFS) [ Time Frame: Approximately 24 months ]
- Determine whether the VMPT combination improves:Response rate, Overall Survival rate, Time and duration of response, Assess the safety, Assess the prognostic factors [ Time Frame: Approximately 24 months ]
|Study Start Date:||May 2006|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm A: VMPT
Induction therapy with nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT) followed by maintenance therapy with Thalidomide and VELCADE
Drug: Bortezomib, Melphalan, Prednisone, Thalidomide
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.
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.
Active Comparator: VMP
Induction therapy with nine 5-week courses of either VELCADE/Melphalan/Prednisone (V-MP).
No maintenance is scheduled.
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
This phase III study represents a prospective randomized open label multicenter trial to evaluate whether the combination of VELCADE, Melphalan, Prednisone and Thalidomide (V-MPT), as induction treatment for newly diagnosed elderly MM patients, improves outcomes compared to the combination VELCADE-MP.
Subjects will be randomized in a 1:1 allocation between:
Arm A: 250 patients: V-MPT treatment Arm B: 250 patients: V-MP treatment Patients excluded from randomization are to be registered in Arm C. Patients randomized in arm A (Thalidomide based) will be further enrolled in the sub-study about the DVT prophylaxis.
Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).
Screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility After registration subjects will be randomized.
Subjects in Arm A will receive:
nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT)
- Maintenance therapy:
Thalidomide in combination with VELCADE
Subjects in Arm B will receive:
nine 5-week courses of VELCADE/Melphalan/Prednisone (V-MP)
- No maintenance therapy is scheduled At the end of induction treatment or at the time of discontinuation of all study drugs, all patients are to attend study center visits on an every 6 to 8-week basis, until development of confirmed Progressive Disease (PD)
- LTFU period:
After development of confirmed PD all patients are to be followed for survival every 3 months via telephone or office visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063179
|A.O.U. S. Giovanni Battista|
|Torino, Italy, 10126|
|Principal Investigator:||Mario Boccadoro, MD||Divisione di Ematologia dell'Università di Torino, A.O.U. S. Giovanni Battista, Torino;Italy|