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Phase 2Phase 2NCT07382739

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 testing Elranatamab in people with Phase 2 and Radiotherapy-Induced Immune Priming, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells. Read more about this study

Who is it for?
Any age
What is being tested?
Elranatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
31 Mar 2026to 31 Dec 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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)
  • 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.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Elra or other agents used in study.
  • History or possible non-compliance with recommended treatments

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christine Ye, MD contact

832-748-6369

jcye@mdanderson.org

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Christine Ye, MD, 832-748-6369, jcye@mdanderson.org

    Christine Ye, MD

    Recruiting

Other trials in United States

About this study

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

Read the detailed description

Primary Objectives 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 (ORR) at 3 months

Secondary Objectives To describe adverse events (AEs). To determine time to next treatment (TTNT). To evaluate progression-free survival (PFS). To determine overall survival (OS). To estimate quality of life (QOL). To assess local control to the irradiated lesions To determine differences in response in patients with EMD vs PMD To determine differences in response in patients High Risk (HR) vs Standard Risk (SR) disease

Being tested
Elranatamab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElranatamabDrug

    Given by IV

Study groups in NCT07382739
Study groupRoleWhat they receive
Treatment with Elranatamab (SubQ) Q4WExperimentalTo evaluate the efficacy of RT-induced immune priming to enhance Elranatamab (Elra) in RRMM with EMD or PMD as measured by overall response rate
Receives: Drug: Elranatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start31 Mar 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07382739
Sponsor's protocol ID
2025-1557
Other IDs
NCI-2026-00668
Status last verified
Sep 2026
First submitted
26 Jan 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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