Phase II Study of Daratumumab Pre-Mobilization and Post-ASCT in Multiple Myeloma
NCT04230031 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-04-21
Summary
This study will use the drug daratumumab in patients who did not achieve at least a very good partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant (ASCT). Daratumumab will be given before the stem cell collection to attempt to get rid of any multiple myeloma cells that may be present in the stem cell collection and after the ASCT to get rid of any multiple myeloma cells that may be remaining.
Conditions
Interventions
- DRUG
-
Experimental
Sponsors & Collaborators
-
Janssen Research & Development, LLC
collaborator INDUSTRY -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Shebli Atrash, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-02
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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