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Withdrawn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

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: Daratumumab
    Pre-ASCT and Post-ASCT: Daratumumab

Primary Outcome Measure

Complete Response (CR) Rate Post-ASCT [ Time Frame: up to 100 days post-ASCT ]

Locations (1)

FacilityCityStateZIPSite coordinators
Levine Cancer InstituteCharlotteNorth Carolina28204-

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