Study on Radiation Therapy and Talquetamab for Treating Multiple Myeloma with Extramedullary Disease

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06572605

This clinical trial is exploring a new treatment approach for multiple myeloma patients with extramedullary disease, using a combination of external beam radiation therapy and the drug talquetamab to target cancer cells outside the bone marrow.

Patient Parameters

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Program Overview

This study is testing the safety and effectiveness of using external beam radiation therapy (EBRT) along with a drug called talquetamab to treat multiple myeloma patients who have extramedullary disease. Extramedullary disease occurs when cancer cells spread to organs and soft tissues outside the bone marrow, making it harder to treat. EBRT uses high-energy beams from outside the body to target and kill cancer cells. Talquetamab is a type of protein that can attach to cancer cells and may help stop them from growing and spreading. The study aims to find out if combining these treatments is safe and effective for patients with this type of multiple myeloma.

Description

The main goals of this study are to see if the combination of radiation therapy and talquetamab is safe and to measure how well it works in shrinking tumors in patients with multiple myeloma that has spread outside the bone marrow.

In the first phase, researchers will focus on the safety of the treatment by monitoring any side effects. In the second phase, they will evaluate how well the treatment works in reducing the cancer.

The study will also look at how the treatment affects the immune system and changes in the cancer environment.

Patients will receive radiation therapy directed at the cancer site once a day for five days, along with talquetamab injections. After this initial period, patients will continue to receive talquetamab every two weeks for up to 13 cycles, as long as the cancer does not progress and side effects are manageable.

Throughout the study, patients will have regular scans and blood tests to monitor their health and the treatment's effectiveness. After completing the treatment, patients will be followed up every month for a year to check on their progress.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Must have a confirmed diagnosis of multiple myeloma with extramedullary disease, meaning the cancer has spread to soft tissues outside the bones.
Must have measurable disease, such as a certain level of cancer markers in the blood or urine, or a tumor that can be measured.
Must have at least one site of extramedullary disease that needs radiation therapy for relief of symptoms like pain or discomfort.
Must have received previous treatments for multiple myeloma, including specific types of drugs.
Must have good overall health, with specific blood counts and organ function within acceptable limits.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after the last dose of talquetamab.
Must agree to provide a sample of tumor tissue for research purposes.

Exclusion Criteria

Have had previous radiation therapy to the target site.
Have received certain types of previous cancer treatments that are not allowed in this study.
Have had major surgery recently or plan to have major surgery during the study.
Have ongoing infections or severe lung diseases like asthma or COPD.
Have certain heart conditions or have had a recent heart attack.
Have active hepatitis B or C infections.
Have other active cancers that could interfere with the study.
Have had a stroke or seizure recently.
Are pregnant or breastfeeding.
Have any other condition that the study doctor believes would make participation unsafe or difficult.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010	Duarte	California

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