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

NCT06572605 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

OTHER

Electronic Health Record Review

Ancillary studies

RADIATION

External Beam Radiation Therapy

Undergo EMD-EBRT

PROCEDURE

Image Guided Biopsy

Undergo image-guided EMD biopsy

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

BIOLOGICAL

Talquetamab

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Scott R Goldsmith · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2030-01-18
Completion
2030-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06572605 on ClinicalTrials.gov