drugset / Trial / NCT02043860

Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma

NCT02043860

Phase 1 Terminated 3 enrolled University of Illinois at Chicago
NaSingle-groupOpen-labelTreatment

Summary

In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.

Timeline

Start
2014-01-10
Primary completion
2016-11-07
Completion
2016-11-07

Drugs

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

Indications