Actively Recruiting
A Phase 1b/2 Study of Talquetamab Plus Priming Radiation Therapy for Multiple Myeloma Patients With Extramedullary Disease
Led by City of Hope Medical Center · Updated on 2025-09-19
20
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the safety and effectiveness of combining external beam radiation therapy (EBRT) directed at extramedullary disease (EMD) with talquetamab treatment for multiple myeloma patients who have EMD. This disease involves cancer cells spreading to organs and soft tissues outside the bones, which is difficult to treat. Talquetamab is a type of protein called a monoclonal antibody that may interfere with cancer growth and spread. During the study, patients receive EBRT once daily for five weekdays targeting the EMD site, alongside talquetamab injections under the skin starting after the first radiation session. After an initial step-up period of up to three talquetamab doses, patients continue to receive talquetamab on days 1 and 15 of each 28-day cycle for up to 13 cycles, unless disease progression or side effects occur. The study includes imaging scans such as CT and PET/CT, blood sample collections, and biopsies at screening and during treatment. Participants are monitored closely for side effects and treatment response through scans, blood tests, and biopsies. Follow-up visits occur every 28 days for up to 12 months after treatment ends. The main outcomes measured include adverse events during treatment and the overall response rate of the EMD. Researchers also assess progression-free survival, duration of response, overall survival, and changes in immune cells and tumor environment.
CONDITIONS
Brief 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 and assent if appropriate
- Agree to allow use of archival tumor tissue or obtain approval if unavailable
- Be 18 years or older
- Karnofsky performance status of 60% or higher
- Diagnosed with multiple myeloma involving extramedullary disease (soft-tissue plasmacytomas not connected to bone lesions)
- Have measurable systemic disease by specified blood or urine markers or plasmacytoma size
- Have at least one extramedullary disease site indicated for palliative radiation
- Targeted extramedullary disease site must fit within one radiation field
- Have received prior treatment with an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody
- Fully recovered from prior anti-cancer therapy side effects (except hair loss) to grade 1 or less
- Completed prior anti-tumor therapies within required time frames before enrollment
- Have absolute neutrophil count of 1,000/mm3 or higher
- Have platelet count of 50,000/mm3 or higher without recent transfusion support
- Hemoglobin level of 8g/dL or higher without recent transfusion or erythropoietin use
- Liver function tests (bilirubin, AST, ALT) within specified limits
- Creatinine clearance of 30 mL/min or higher
- Women of childbearing potential must have negative pregnancy tests
- Agree to use effective birth control or abstain from heterosexual activity during study and 6 months after last dose
You will not qualify if you...
- Prior radiation to the targeted extramedullary disease site or field
- Prior treatment with GPRC5D therapy or radiopharmaceutical therapy
- Previous radiation to more than 25% of bone marrow
- Recent allogeneic or autologous hematopoietic cell transplantation within specified periods
- High cumulative corticosteroid dose within 14 days before starting study treatment
- Major surgery within 2 weeks before or planned during study treatment period
- Ongoing or active infection
- Severe persistent asthma or severe chronic obstructive pulmonary disease
- Certain severe heart conditions including advanced heart failure or recent heart attack
- Active hepatitis B or C infection
- Plasma cell leukemia or certain other blood disorders
- Active central nervous system involvement by multiple myeloma
- Other active cancers that might interfere with study assessments
- Stroke or seizure within 6 months before enrollment
- Allergic reactions to similar compounds as the study drug
- HIV positive with uncontrolled infection or recent changes in treatment
- Pregnant or breastfeeding women
- Any other condition that would make participation unsafe or prevent compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 week
Participants undergo external beam radiation therapy (EMD-EBRT) once daily for 5 treatment fractions on weekdays and receive talquetamab subcutaneously starting after the first radiation fraction, continuing every 2-4 days for up to 3 step-up doses if tolerated.
5 visits for radiation therapy on weekdays and up to 3 talquetamab dosing visits during this period
Duration - Up to 13 cycles of 28 days each
Starting 2-7 days after the last step-up dose, participants receive talquetamab subcutaneously on days 1 and 15 of each 28-day cycle, for up to 13 cycles unless disease progression or unacceptable toxicity occurs.
2 visits per 28-day cycle for talquetamab administration
Duration - Up to 12 months
After completion of study treatment, participants are followed up every 28 days for up to 12 months to monitor safety and efficacy outcomes.
Monthly follow-up visits every 28 days
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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