RecruitingPhase 1Phase 2NCT07181941

Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma

Pharmacodynamically Monitored Linvoseltamab Dosing De-Escalation in Relapsed Multiple Myeloma


Sponsor

Fred Hutchinson Cancer Center

Enrollment

30 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial evaluates the safety and feasibility of early, response-based dose reduction of linvoseltamab in the treatment of patients multiple myeloma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is resistant to three classes of therapeutic agents, including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies (triple-class relapsed/refractory). Linvoseltamab is a bispecific antibody. Upon administration, linvoseltamab binds to the BCMA protein on cancer cells and the CD3 protein on T cells (a type of immune cell). This generates an immune response that stimulates the T cells to kill the cancer cells. Optimal dosing schedules of linvoseltamab have not yet been determined. Reducing the dosage of linvoseltamab may reduce treatment-related side effects while maintaining long-term disease outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether patients with multiple myeloma who respond very well to linvoseltamab (a bispecific antibody drug that engages the immune system) can safely reduce their dosing frequency — potentially from monthly to every 2-3 months — without the cancer coming back. **You may be eligible if...** - You are 18 or older - You have been diagnosed with active multiple myeloma meeting standard diagnostic criteria - Your myeloma is measurable (detectable through blood, urine, or light chain tests) - Your doctor has considered you for linvoseltamab treatment **You may NOT be eligible if...** - You have a type of myeloma that cannot be measured or evaluated for response - You have serious infections, organ failure, or other conditions that make treatment unsafe - You are unable to provide informed consent 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

BIOLOGICALLinvoseltamab

Given IV

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREBiospecimen Collection

Undergo collection of blood samples


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT07181941


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