drugset / Trial / NCT01592370

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

NCT01592370 ↗

Phase 1/2 Completed 320 enrolled Bristol-Myers Squibb Janssen, LP · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

Timeline

Start
2012-08-02
Primary completion
2020-09-25
Completion
2024-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Subject Dexamethasone Small molecule 4 mg Oral
Subject Dexamethasone Small molecule 16 mg Oral
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Ipilimumab Monoclonal antibody — Intravenous
Subject Lirilumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Pomalidomide Other / unclassified 4 mg Oral