Phase II Study of Daratumumab Pre-Mobilization and Post-ASCT in Multiple Myeloma
Part of paid clinical trials in Charlotte, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT04230031
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab — DRUGExperimental
Study Details
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.
Key Dates
- Start date
- Jul 2, 2021
- Status verified
- Mar 2022
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1: DaratumumabPre-ASCT and Post-ASCT: Daratumumab
Primary Outcome Measure
Complete Response (CR) Rate Post-ASCT [ Time Frame: up to 100 days post-ASCT ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | - |
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