drugset
drugset / Trial / NCT03215524

A Study Of Daratumumab, Low-Dose Oral Dexamethasone and Cyclophosphamide With Or Without Pomalidomide

NCT03215524 ↗

Phase 2 Completed 120 enrolled Canadian Myeloma Research Group
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized phase II open label study of daratumumab, weekly low-dose oral cyclophosphamide and dexamethasone with or without pomalidomide in patients with relapsed and refractory multiple myeloma. The study consists of two arms. Patients will be randomized into ARM A and ARM B in a 1:1 ratio.

Timeline

Start
2017-10-25
Primary completion
2022-06-24
Completion
2022-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Pomalidomide Other / unclassified 4 mg Oral
Background Cyclophosphamide Other / unclassified 400 mg Oral
Background Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Background Daratumumab Monoclonal antibody 1800 mg Intravenous
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral

Indications

plasma cell myeloma