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

NCT03215524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

DCdP

Daratumumab, Cyclophosphamide, Dexamethasone, Pomalidomide

BIOLOGICAL

DCd+P

Daratumumab, Cyclophosphamide, Dexamethasone, + Pomalidomide added only at first confirmed biochemical progression

Sponsors & Collaborators

  • Canadian Myeloma Research Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215524 on ClinicalTrials.gov