RecruitingPhase 2NCT07657312

Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma


Sponsor

Naresh Bumma

Enrollment

35 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect the lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible paralysis and/or coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Bone Marrow Biopsy, and others for people with cytokine release syndrome, recurrent multiple myeloma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo PET-CT

BIOLOGICALInfliximab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET-CT

BIOLOGICALTalquetamab

Given SC

DRUGTeclistamab

Given SC

PROCEDUREX-Ray Imaging

Undergo x-ray


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07657312


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