Actively Recruiting

Phase 2
All Genders
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"

Led by M.D. Anderson Cancer Center · Updated on 2026-04-14

34

Participants Needed

1

Research Sites

248 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

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

CONDITIONS

Official 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

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with relapsed refractory multiple myeloma exposed to IMID, PI, anti-CD38 monoclonal antibody
  • Relapsed disease with progression more than 60 days after prior therapy or refractory disease with progression within 60 days or less
  • At least one site of extramedullary or paramedullary disease confirmed by PET/CT or MRI
  • At least one lesion suitable for radiation that has not been previously treated with radiation
  • Hemoglobin level 7 g/dL or higher
  • Platelet count 50,000/uL or higher
  • Absolute neutrophil count 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 upper limit of normal unless Gilbert syndrome
  • Creatinine clearance of 30 mL/min/1.73 m2 or higher
  • ECOG performance status 0 to 2, or potentially improved to 2 if due to myeloma-related symptoms
  • Women of childbearing potential must have negative pregnancy tests and use effective contraception until 6 months after last dose
  • Participants not of childbearing potential can also participate
Not Eligible

You will not qualify if you...

  • Recent use of investigational treatments within 14 days or 5 half-lives prior to study treatment
  • Use of IMIDs, PI, anti-CD38 monoclonal antibodies, or cytotoxic therapies within 7 days prior to treatment
  • Autologous stem cell transplant within 12 weeks or allogeneic transplant within 6 months without being off immunosuppressive agents for at least 42 days
  • Major surgery within 2 weeks prior to treatment
  • Stroke or cerebrovascular accident within 6 months
  • Diagnosis of Waldenstrom, POEMS, amyloidosis, or ongoing plasma cell leukemia
  • History of HIV infection
  • Active uncontrolled hepatitis B infection despite treatment
  • Uncontrolled heart, lung, gastrointestinal, liver, kidney, or nervous system diseases not related to myeloma
  • Uncontrolled or recurrent infections
  • Autoimmune diseases requiring systemic treatment except low-dose steroids
  • Psychiatric disorders, substance abuse, dementia, or altered mental status
  • Other active cancers within 5 years except certain treated breast or prostate cancers
  • Myelodysplastic syndromes
  • Allergic reactions to drugs similar to elranatamab
  • Issues preventing treatment adherence or understanding of the study
  • History of non-compliance with medical treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

C

Christine Ye, MD

CONTACT

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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