Trials / Recruiting
RecruitingNCT07382739
A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells.
Detailed description
Primary Objectives To evaluate the efficacy of RT-induced immune priming to enhance Elranatamab (Elra) in RRMM with EMD or PMD as measured by overall response rate (ORR) at 3 months Secondary Objectives To describe adverse events (AEs). To determine time to next treatment (TTNT). To evaluate progression-free survival (PFS). To determine overall survival (OS). To estimate quality of life (QOL). To assess local control to the irradiated lesions To determine differences in response in patients with EMD vs PMD To determine differences in response in patients High Risk (HR) vs Standard Risk (SR) disease
Conditions
- Phase 2
- Radiotherapy-Induced Immune Priming
- Elranatamab
- Relapsed Refractory Multiple Myeloma (RRMM)
- Extramedullary Disease in Multiple Myeloma
- Paramedullary Disease
- PMD
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elranatamab | Given by IV |
Timeline
- Start date
- 2026-03-31
- Primary completion
- 2028-12-31
- Completion
- 2030-12-31
- First posted
- 2026-02-03
- Last updated
- 2026-04-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07382739. Inclusion in this directory is not an endorsement.