drugset / Trial / NCT03768960

A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

NCT03768960

Phase 4 Completed 150 enrolled Johnson & Johnson Private Limited
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate the safety profile of daratumumab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent.

Timeline

Start
2019-06-10
Primary completion
2022-07-16
Completion
2022-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumab Monoclonal antibody 16 mg/kg

Indications