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"

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" (NCT07382739) is a Phase 2 interventional studying Phase 2 and Radiotherapy-Induced Immune Priming, sponsored by M.D. Anderson Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Phase 2 and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 34 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria - 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: 1. Relapsed disease: progressive disease (PD) \>60 days after cessation of prior therapy 2. Refractory disease: PD \<=60 days after cessation of prior therapy, \<25% reduction in paraprotein (monoclonal protein \[M-protein\] or serum free light chains \[sFLC\]) or measurements of EMD/PMD - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria * 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: 1. Relapsed disease: progressive disease (PD) \>60 days after cessation of prior therapy 2. Refractory disease: PD \<=60 days after cessation of prior therapy, \<25% reduction in paraprotein (monoclonal protein \[M-protein\] or serum free light chains \[sFLC\]) or measurements of EMD/PMD * 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 Criteria 1. Prior or concurrent exposure to any of the following in the specified time frame prior to the first dose of Elra treatment: * 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

Treatments Being Tested

DRUG

Elranatamab

Given by IV

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

MD Anderson Cancer Center

Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07382739), the sponsor (M.D. Anderson Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07382739 clinical trial studying?

To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07382739?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07382739?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07382739. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07382739. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.