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PRIME-EMD-PMD: A Study of Radiotherapy and Elranatamab for Multiple Myeloma

This study, called PRIME-EMD-PMD, is looking at how low doses of radiation therapy might help a drug called elranatamab work better for people with relapsed or refractory multiple myeloma (a type of blood cancer) that has spread outside the bone marrow (extramedullary disease) or near the spinal cord (paramedullary disease). You might be able to join if your multiple myeloma has come back or isn't responding to at least one previous treatment, including certain common therapies. The main goal is to see how safe this combination is and what side effects might occur. Researchers also want to see if this treatment can shrink your cancer. The study plans to enroll 34 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 2 study, and it plans to enroll 34 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07382739

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"

Recruiting
PHASE2All AgesInterventionalTreatment
M.D. Anderson Cancer Center
~34 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:Elranatamab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Phase 2
Radiotherapy-Induced Immune Priming
Elranatamab
Relapsed Refractory Multiple Myeloma (RRMM)
Extramedullary Disease in Multiple Myeloma
Paramedullary Disease
PMD

Explore related trials

Multiple Myeloma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Christine Ye, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Christine Ye, MD
[email protected]
832-748-6369
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

RRMM exposed to IMID, PI, anti-CD38 mAb, relapsed or refractory to at least one prior line of therapy (LOT), progressed on or after the last regimen:
Diagnosis of relapsed or refractory multiple myeloma as indicated by progression by IMWG criteria
At least one locus of EMD or PMD present on imaging (either PET/CT or magnetic resonance imaging \[MRI\]):
EMD: extramedullary plasmacytoma, not a contiguous extension from a bone lesion.
PMD: paraskeletal plasmacytoma, contiguous extension from a bone lesion At least one locus of EMD/PMD that was not previously radiated and can be treated with radiation
Hematology (supportive care is allowed, including transfusions and granulocyte colony stimulating factor (G-CSF), if cytopenia is deemed secondary to myeloma disease burden):
Hemoglobin (Hgb) \>=7g/dL
Platelet\>=50K/uL
Absolute neutrophil count (ANC) \>=0.75K/uL
Chemistry:
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \<=2.5 x upper
limit of normal (ULN)
Total bilirubin (TBili) \<=1.5ULN (except for a known history of Gilbert syndrome)
Creatinine clearance (CrCL) \>=30mL/min/1.73m2
Eastern Cooperative Oncology Group Performance Status (ECOG PS) \<=2, unless ECOG PS due to pain/morbidity secondary to underlying myeloma disease, with the potential of improved ECOG PS to \<=2.
All participants must be either
Not of childbearing potential, or
Practicing at least 1 highly effective method of contraception until 6 months after the last dose of study treatment.
Childbearing age female participantsmust have a negative serum pregnancy test at screening and must agree to further pregnancy tests during the study.

Exclusion

Within 14 days or at least 5 half-lives, whichever is less, of any investigational treatment
Within 7 days of IMIDs, PI, anti-CD38 mAb, or cytotoxic systemic myeloma therapies
Within 12 weeks of autologous stem-cell therapy (ASCT) or 6 months of AlloSCT and has to be off immunosuppressive agents \>=42 days without signs of graft versus host disease (GVHD)
Within 2 weeks of major surgery
Within 6 months of cerebrovascular accident (CVA) events 2. Waldenstrom, POEMS, Amyloidosis, ongoing plasma cell leukemia (PCL) 3. History of Human Immunodeficiency Virus (HIV) 4. Active, uncontrolled HBV infection despite antiviral therapy. 5. Uncontrolled cardiac, pulmonary, gastrointestinal (GI), hepatic, renal, central nervous system(CNS) diseases not due to myeloma, at the discretion of investigator, that are not a candidate for T cell engager (TCE) therapy 6. Uncontrolled or recurrent infections 7. Autoimmune disease requiring systemic treatment (except for low dose steroids, equivalent to 10mg/day or less of prednisone) 8. Disabling psychiatric conditions, substance abuse (alcohol, or drug), dementia, altered mental status 9. Any other active malignancies within 5 years of completing treatment (with the exception of hormonal therapies for breast or prostate cancer) and \>minimal risk of recurrence 10. Myelodysplastic syndromes (MDS) 11. Any issues that may impair the ability of the participant to receive or tolerate the planned treatment, to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that would prevent, limit, or confound the protocol specified assessments. 12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Elra or other agents used in study. 13. History or possible non-compliance with recommended treatments

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0