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

NCT01063179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2023-06-29

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Principal Investigators

  • Mario Boccadoro, MD · Divisione di Ematologia dell'Università di Torino, A.O.U. S. Giovanni Battista, Torino;Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063179 on ClinicalTrials.gov