NCT01063179

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-02-05
• Last updated: 2023-06-29

Locations

1 site across 1 country: Italy