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
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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