drugset / Trial / NCT00505895

FM 140 vs FM100 Study in Patients With Multiple Myeloma

NCT00505895 ↗

Phase 2 Completed 52 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.

Timeline

Start
2002-01
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 100 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications