RecruitingPhase 1Phase 2NCT06572605

External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease

A Phase 1b/2 Study of Talquetamab Plus Concomitant Priming Radiotherapy in Multiple Myeloma With Extramedullary Disease


Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the safety and effectiveness of extramedullary disease (EMD)-directed external beam radiation therapy (EBRT) in combination with talquetamab for the treatment of multiple myeloma patients with extramedullary disease. Extramedullary disease in multiple myeloma involves the infiltration of organs and soft tissues by malignant plasma cells and has proven difficult to treat. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink cancers. EBRT is a type of radiation therapy that delivers high-energy beams to the cancer from outside of the body. In this trial, the EBRT will be directed to a site of extramedullary disease. Talquetamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Combining EMD-directed EBRT with talquetamab may be safe, tolerable, and/or effective in treating multiple myeloma patients with extramedullary disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of targeted radiation therapy with a drug called talquetamab for people with multiple myeloma (a blood cancer) that has spread outside the bone marrow into soft tissues — known as extramedullary disease. Talquetamab targets a protein on myeloma cells called GPRC5D. **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma with extramedullary disease (soft tissue tumors not attached to bone) - You have measurable myeloma in your blood or urine - Your performance status allows you to function reasonably well (Karnofsky ≥60%) **You may NOT be eligible if...** - You do not have extramedullary disease - You have serious infections, organ problems, or immune conditions that make this treatment unsafe - You are pregnant 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

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT and/or PET/CT

OTHERElectronic Health Record Review

Ancillary studies

RADIATIONExternal Beam Radiation Therapy

Undergo EMD-EBRT

PROCEDUREImage Guided Biopsy

Undergo image-guided EMD biopsy

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALTalquetamab

Given SC


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06572605


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