drugset / Trial / NCT02489500

Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib

NCT02489500

Phase 3 Terminated 3 enrolled Boston Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant. This study will compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.

Timeline

Start
2015-06
Primary completion
2017-04-28
Completion
2017-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2
Background Melphalan Small molecule 70 mg/m2
Background Melphalan Small molecule 100 mg/m2
Background filgrastim Protein / enzyme biologic 16 ug/kg

Indications