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
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).
1. Pre-treatment period:
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.
2. Treatment period:
Subjects in Arm A will receive:
1. Induction therapy:
nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT)
2. Maintenance therapy:
Thalidomide in combination with VELCADE
Subjects in Arm B will receive:
1. Induction therapy:
nine 5-week courses of VELCADE/Melphalan/Prednisone (V-MP)
2. 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)
3. LTFU period:
After development of confirmed PD all patients are to be followed for survival every 3
months via telephone or office visit.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine whether the V-MPT combination improves progression free survival (PFS)
Approximately 24 months
Mario Boccadoro, MD
Divisione di Ematologia dell'Università di Torino, A.O.U. S. Giovanni Battista, Torino;Italy
Italy: Ministry of Health