drugset / Trial / NCT03871829

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

NCT03871829

Phase 2 Terminated 88 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy (rate of very good partial response \[VGPR\] or better as best response as defined by the International Myeloma Working Group \[IMWG\] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

Timeline

Start
2019-05-31
Primary completion
2022-10-24
Completion
2023-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Background Carfilzomib Other / unclassified 20 mg/m2 Intravenous
Background Carfilzomib Other / unclassified 70 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg Intravenous
Background Dexamethasone Small molecule 40 mg Intravenous

Indications