Trials / Recruiting
RecruitingNCT06483100
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elrantamab | \- Elranatamab will be dosed in 28-day cycles as follows: * C1D1: 12 mg SC priming dose * C1D3: 32 mg SC priming dose * C1D8, C1D15, C1D22: 76 mg SC * Cycle 2-Cycle 7: 76 mg SC on D1 and D15 * Cycle 8 and subsequent cycles: 76 mg SC on D1 |
| DEVICE | clonoSEQ | FDA approved MRD testing |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2031-12-31
- Completion
- 2031-12-31
- First posted
- 2024-07-03
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06483100. Inclusion in this directory is not an endorsement.