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

StatusSuspended
PhasePhase 1/2
Started2025-08-29
View on ClinicalTrials.gov ↗

Amendment history

2026-09-05
critical
Recruiting→Suspended Study Status, Contacts/Locations v5
Recruitment suspended: pending amendment
Trial statusRecruiting→Suspended
Study sitesdetails revised at 1 of 1 site
2025-09-15
minor
Study Status v4
Start dateestimated 2025-10-01→confirmed 2025-08-29
2025-08-05
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-06-30→2030-01-18
Completion date2028-06-30→2030-01-18
Start date2025-07-01→2025-10-01
Study sitesdetails revised at 1 of 1 site
2025-04-09
minor
Study Status v2
Start date2025-03-01→2025-07-01
2025-01-13
minor
Study Status v1
Start date2024-12-15→2025-03-01
2024-08-23
minor
Original filing
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.
Trial Details
NCT Number NCT06572605
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Extramedullary Disease in Multiple Myeloma, Multiple Myeloma
Enrollment 20 participants
Start Date 2025-08-29
Primary Completion 2030-01-18 (estimated)
Study Completion 2030-01-18 (estimated)
Updated on ClinicalTrials.gov 2026-09-10