drugset / Trial / NCT03011034

Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

NCT03011034

Phase 2 Completed 34 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of the study is to evaluate the efficacy (transfusion independence \[TI\]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).

Timeline

Start
2017-02-14
Primary completion
2019-01-23
Completion
2021-10-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Subject Talacotuzumab Monoclonal antibody 9 mg/kg Intravenous