drugset
drugset / Trial / NCT04268498

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

NCT04268498 ↗

Phase 2 Active not recruiting 310 enrolled University of Miami Amgen · collabJanssen Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is being done to find out whether carfilzomib, lenalidomide, and dexamethasone (KRD) or KRD and Daratumumab (KRD+DARA) might be safer and more effective ways of controlling multiple myeloma than the standard of care treatment, which is lenalidomide, bortezomib, and dexamethasone (VRD).

Timeline

Start
2020-02-11
Primary completion
2027-02-01
Completion
2027-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Subject Carfilzomib Other / unclassified 56 mg/m2 Intravenous
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Subject Daratumumab Monoclonal antibody 1800 mg Intravenous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral
Background Acetaminophen Small molecule 650 mg Oral
Background Diphenhydramine Unknown 25 mg Intravenous
Background Montelukast Other / unclassified 10 mg Oral

Indications

plasma cell myeloma