Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT06207799
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Multiple Myeloma
- Post-transplant MRD-guided Maintenance Therapy
- Pre-transplant Purging
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Elranatamab — DRUGGiven by SC
- Lenalidomide — DRUGGiven by PO
- Plerixafor — DRUGGiven by SC
- Melphalan — DRUGGiven by IV
- Busulfan — DRUGGiven by PO
- G-CSF — DRUGGiven by IV
- Stem cell transplant — PROCEDUREGiven by IV
Study Details
To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.
Key Dates
- Start date
- Jul 17, 2024
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Elranatamab1. Induction therapy - This is given to decrease the number of MM cells in the bone marrow. 2. Purging - This is done to remove leftover MM cells after induction therapy. 3. Stem cell mobilization - This is done to move stem cells from your bone marrow into the blood, so they can be collected for the autologous stem cell transplant. 4. Conditioning therapy - This is given to help prepare the body to receive the stem cell transplant. 5. Autologous stem cell transplant 6. Maintenance therapy - This is given to help control the disease after the stem cell transplant.
Primary Outcome Measure
Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]
Central Contacts
- Qaiser Bashir, MD(713) 794-4422
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | Qaiser Bashir, MD (PRINCIPAL_INVESTIGATOR) |
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