drugset / Trial / NCT00560053

Pethema Multiple Myeloma 2000

NCT00560053

Phase 3 Completed 500 enrolled PETHEMA Foundation
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation.

Timeline

Start
2000-01
Primary completion
Completion
2005-02

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 10 mg/kg
Subject Dexamethasone Small molecule 40 mg/m2
Subject Doxorubicin Other / unclassified 40 mg/m2
Subject Melphalan Small molecule 0.25 mg/kg Oral
Subject Prednisone Other / unclassified 50 mg Oral
Subject Vcr Unknown 2 mg Intravenous
Subject carmustine Small molecule 0.5 mg/kg Intravenous
Subject interferon alfa-2b Protein / enzyme biologic Subcutaneous

Indications