Actively Recruiting
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
Led by City of Hope Medical Center · Updated on 2025-09-19
20
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent
- Agree to allow use of archival tissue from diagnostic tumor biopsies or obtain approval for exceptions
- Be 18 years of age or older
- Have a Karnofsky performance status of 60% or higher
- Have a diagnosis of multiple myeloma with extramedullary disease (EMD) defined as soft-tissue plasmacytomas not arising from bone lesions
- Have measurable systemic disease with specific laboratory or tumor size criteria
- Have at least one EMD site eligible for palliative radiation treatment
- Target EMD site must be covered by a single radiation field
- Have received prior treatment with an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody
- Be fully recovered from prior non-blood-related cancer treatment side effects to grade 1 or less (except hair loss)
- Complete prior anti-cancer therapy within specified timeframes before enrollment
- Have absolute neutrophil count of 1,000/mm3 or higher
- Have platelet count of 50,000/mm3 or higher without transfusion support within 7 days
- Have hemoglobin of 8 g/dL or higher without transfusion support within 7 days
- Have total bilirubin less than or equal to 2.0 times the upper normal limit (or 1.5 times for certain conditions)
- Have liver enzymes (AST and ALT) less than or equal to 2.5 times upper normal limit
- Have creatinine clearance of 30 mL/min or higher
- For women of childbearing potential, have negative pregnancy tests
- Agree to use effective birth control or abstain from heterosexual activity during the study and for 6 months after last dose
- Childbearing potential defined as not surgically sterilized or not free from menses for more than 1 year
You will not qualify if you...
- Prior radiation to the target extramedullary disease site
- Prior treatment with GPRC5D therapy or radiopharmaceutical therapy
- Received radiation to more than 25% of bone marrow
- Recent allogeneic hematopoietic cell transplant within 6 months or autologous transplant within 12 weeks
- High-dose corticosteroid use within 14 days before study drug
- Major surgery within 2 weeks before or planned during the study treatment period
- Ongoing or active infection
- Severe persistent asthma or severe chronic obstructive pulmonary disease
- Certain serious heart conditions including advanced heart failure, recent heart attack or surgery, uncontrolled arrhythmias, or severe cardiomyopathy
- Active hepatitis B or C infection unless effectively treated
- Plasma cell leukemia or specific other blood disorders
- Active central nervous system involvement of multiple myeloma
- Other active cancers that may interfere with study assessment
- Stroke or seizure within 6 months prior to enrollment
- History of allergic reactions to similar compounds
- For HIV positive participants, detectable viral load, low CD4 count, recent AIDS-defining infections, or recent changes in antiretroviral therapy
- Pregnant or breastfeeding females
- Any condition or circumstance that would prevent safe participation or compliance with study procedures based on investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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