drugset / Trial / NCT00652041

Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma

NCT00652041

Phase 4 Completed 40 enrolled PETHEMA Foundation
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients \> 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients \<= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.

Timeline

Start
2007-01
Primary completion
2010-01
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Adriamicine Unknown 40 mg/m2 Intravenous
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified
Subject Dexamethasone Small molecule
Subject Doxorubicin Other / unclassified 30 mg/m2 Intravenous
Subject Melphalan Small molecule 9 mg/m2 Oral
Subject Prednisone Other / unclassified 60 mg/m2 Oral
Subject Thalidomide Other / unclassified 200 mg Oral

Indications