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"

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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

EMD: extramedullary plasmacytoma, not a contiguous extension from a bone lesion.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Elranatamab
Drug
Given by IV

Treatment groups

34 Participants

are divided into 1 treatment group

Group A: Treatment with Elranatamab (SubQ) Q4WExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov

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