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 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-1557NCI-2026-00668
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

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

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Elranatamab (SubQ) Q4W

EXPERIMENTAL

To evaluate the efficacy of RT-induced immune priming to enhance Elranatamab (Elra) in RRMM with EMD or PMD as measured by overall response rate

Drug: Elranatamab

Interventions

Elranatamab DRUG

Given by IV

Treatment with Elranatamab (SubQ) Q4W

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Relapsed disease: progressive disease (PD) \>60 days after cessation of prior therapy
• 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)

You may not qualify if:

• 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
• Waldenstrom, POEMS, Amyloidosis, ongoing plasma cell leukemia (PCL)
• History of Human Immunodeficiency Virus (HIV)
• Active, uncontrolled HBV infection despite antiviral therapy.
• 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
• Uncontrolled or recurrent infections
• Autoimmune disease requiring systemic treatment (except for low dose steroids, equivalent to 10mg/day or less of prednisone)
• Disabling psychiatric conditions, substance abuse (alcohol, or drug), dementia, altered mental status
• 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
• Myelodysplastic syndromes (MDS)

Sponsors & Collaborators

• Pfizer: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christine Ye, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Ye, MD

CONTACT

832-748-6369; jcye@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)