Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study will evaluate whether the combination of VELCADE, Thalidomide , Melphalan
      and Prednisone (V-MPT), as induction treatment for newly diagnosed elderly MM patients,
      improves outcomes compared to the combination VELCADE-MP.
    

Detailed description: 
      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.
    

Intervention name(s): Bortezomib, Melphalan, Prednisone, Thalidomide; Bortezomib, Melphalan, Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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
Other intervention name(s): Bortezomib; Velcade; Thalidomide; Boirtezomib; velcade
Intervention MeSH terms: Thalidomide; Prednisone; Bortezomib; Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Elderly patients; Bortezomib; Thalidomide