drugset / Trial / NCT02918331

A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation

NCT02918331

Phase 1 Completed 7 enrolled Janssen Pharmaceutical K.K.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).

Timeline

Start
2016-09
Primary completion
2017-10
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Background Dexamethasone Small molecule 40 mg
Background Lenalidomide Other / unclassified 10 mg Oral
Background Lenalidomide Other / unclassified 25 mg Oral

Indications