drugset / Trial / NCT02043847

TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)

NCT02043847

Phase 1 Completed 12 enrolled University of Illinois at Chicago
Non-randomizedSequentialOpen-labelTreatment

Summary

In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.

Timeline

Start
2014-01-14
Primary completion
2016-09-14
Completion
2016-09-14

Drugs

EvaluationDrugModalityDoseRoute
Background Melphalan Small molecule 200 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous