Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
NCT06483100 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2026-04-13
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
- 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
Sponsors & Collaborators
-
National Comprehensive Cancer Network
collaborator NETWORK - collaborator INDUSTRY
-
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Michael Slade, M.D. · Washington University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-20
- Primary Completion
- 2031-12-31
- Completion
- 2031-12-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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