RecruitingPhase 2NCT06483100

Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance


Sponsor

Washington University School of Medicine

Enrollment

65 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called elranatamab — a type of immune therapy (bispecific antibody) that helps the immune system find and destroy multiple myeloma cells — can be used as maintenance therapy after a stem cell transplant in patients whose myeloma is still detectable by highly sensitive testing (measurable residual disease, or MRD). **You may be eligible if...** - You are 18 or older with newly diagnosed IgG or IgA multiple myeloma - You received an autologous stem cell transplant (using your own stem cells) as part of your initial treatment - Sensitive testing shows residual myeloma cells are still present after transplant (MRD positive) - Your overall health is adequate for treatment **You may NOT be eligible if...** - Your myeloma is MRD-negative after transplant (no detectable residual disease) - You have another active cancer being treated - You have significant organ damage or active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElrantamab

\- 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

DEVICEclonoSEQ

FDA approved MRD testing


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06483100


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