OncoMatch/Clinical Trials/NCT07657312
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
Is NCT07657312 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments including Infliximab and Talquetamab for cytokine release syndrome.
Treatment: Infliximab · Talquetamab · Teclistamab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunomodulatory agent
Patients must have had at least 4 prior lines of therapy including an immunomodulatory agent (IMID), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
Must have received: proteasome inhibitor
Patients must have had at least 4 prior lines of therapy including an immunomodulatory agent (IMID), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
Must have received: anti-CD38 monoclonal antibody
Patients must have had at least 4 prior lines of therapy including an immunomodulatory agent (IMID), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
Lab requirements
Blood counts
Hemoglobin ≥ 7g/dL; ANC ≥ 1000/µL; Platelets ≥ 50,000/µL
Kidney function
Calculated creatinine clearance of ≥ 30ml/min using MDRD formula
Liver function
Total bilirubin ≤ 1.5 X ULN; AST, ALT, and alkaline phosphatase < 2.5 X ULN
Cardiac function
Left ventricular ejection fraction ≥ 30%; no uncontrolled arrhythmias; no NYHA class III-IV heart failure; 12-lead ECG with QTcF ≤ 470 msec
Hemoglobin ≥ 7g/dL; ANC ≥ 1000/µL; Platelets ≥ 50,000/µL; Total bilirubin ≤ 1.5 X ULN; AST, ALT, and alkaline phosphatase < 2.5 X ULN; Calculated creatinine clearance of ≥ 30ml/min using MDRD formula; Left ventricular ejection fraction ≥ 30%; no uncontrolled arrhythmias; no NYHA class III-IV heart failure; 12-lead ECG with QTcF ≤ 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07657312 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received immunomodulatory agent and proteasome inhibitor.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages