drugset / Trial / NCT00388635

Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.

NCT00388635

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This protocol is planned as a multicentric, national, open-label trial designed to evaluate, first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone. After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003

Timeline

Start
2004-04
Primary completion
2007-01
Completion
2008-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2
Subject Bortezomib Small molecule 1.3 mg/m2
Background Melphalan Small molecule 9 mg/m2 Oral
Background Prednisone Other / unclassified 60 mg/m2 Oral

Indications