drugset / Trial / NCT01359657

Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT01359657

Phase 1 Completed 46 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.

Timeline

Start
2011-09
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulocuplumab Monoclonal antibody 1 mg/kg Intravenous
Subject Ulocuplumab Monoclonal antibody 10 mg/kg Intravenous
Background Bortezomib Small molecule 1.3 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg Oral
Background Lenalidomide Other / unclassified 25 mg Oral

Indications