Actively Recruiting
Phase 2 Study of Radiotherapy-Induced Immune Priming to Enhance Elranatamab in Relapsed Refractory Multiple Myeloma with Extramedullary and Paramedullary Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-04-14
34
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether low doses of radiation therapy can help the drug elranatamab improve its ability to kill cancer cells in patients with relapsed or refractory multiple myeloma who also have extramedullary or paramedullary disease. This phase 2 study aims to evaluate the overall response rate at 3 months and to understand safety, time to next treatment, progression-free survival, overall survival, quality of life, and local control of irradiated lesions. Participants will receive elranatamab given intravenously along with radiotherapy aimed at priming the immune system to enhance the drug's effect on cancer cells. The study focuses on treating lesions that have not been previously radiated and can be targeted with radiation. This trial is sponsored by M.D. Anderson Cancer Center and involves monitoring response differences between patients with extramedullary versus paramedullary disease and between high-risk and standard-risk groups. During the study, participants will be closely monitored for safety and adverse events for about one year. Researchers will collect data on treatment effects, quality of life, and disease progression. Assessments will include imaging to confirm disease location, blood tests to monitor blood counts and organ function, and performance status evaluations. The total duration of participation depends on individual treatment and follow-up needs throughout the study.
CONDITIONS
Brief Title
A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory multiple myeloma exposed to IMID, PI, anti-CD38 mAb, and progressed on or after at least one prior line of therapy
- Relapsed disease with progression more than 60 days after stopping prior therapy or refractory disease with progression within 60 days or less
- At least one extramedullary or paramedullary lesion visible on PET/CT or MRI that was not previously radiated and can be treated with radiation
- Hemoglobin level of 7 g/dL or higher
- Platelet count of 50,000 per microliter or higher
- Absolute neutrophil count of 0.75 K/uL or higher
- Liver enzymes (AST, ALT) less than or equal to 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (except Gilbert syndrome)
- Creatinine clearance of 30 mL/min/1.73m2 or higher
- ECOG performance status of 2 or less unless due to myeloma-related pain with potential to improve
- Not of childbearing potential or using at least one highly effective contraception method during and for 6 months after treatment
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to ongoing testing
You will not qualify if you...
- Prior or recent exposure to investigational treatments within 14 days or 5 half-lives before first dose
- Recent use (within 7 days) of IMIDs, PI, anti-CD38 mAb, or cytotoxic systemic therapies
- Recent autologous stem-cell therapy within 12 weeks or allogeneic stem-cell therapy within 6 months with ongoing immunosuppression or graft versus host disease
- Recent major surgery within 2 weeks
- Cerebrovascular accident within 6 months
- Diagnosed with Waldenstrom, POEMS, Amyloidosis, or ongoing plasma cell leukemia
- History of HIV infection
- Active uncontrolled hepatitis B infection
- Uncontrolled cardiac, pulmonary, gastrointestinal, hepatic, renal, or central nervous system diseases not due to myeloma
- Uncontrolled or recurrent infections
- Autoimmune disease requiring systemic treatment except low-dose steroids (10 mg/day prednisone or less)
- Disabling psychiatric conditions, substance abuse, dementia, or altered mental status
- Other active cancers within 5 years except certain hormonal therapies
- Myelodysplastic syndromes
- Any condition impairing ability to participate or tolerate treatment
- History of allergic reactions to elranatamab or similar agents
- History or possible non-compliance with treatments
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 visit (in-person)
Duration - Up to approximately 1 year
Participants receive Elranatamab by intravenous administration along with radiotherapy-induced immune priming to treat relapsed refractory multiple myeloma with extramedullary or paramedullary disease.
Regular visits for treatment and assessments (frequency as per protocol)
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Christine Ye, MD
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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