Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in… (NCT07657312) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
United States35 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by IMWG criteria and measurable disease as defined by any of the following:
* Serum M-protein ≥ 0.5 g/dl
* Urine monoclonal protein ≥ 200 mg/24h
* Involved free light chain (FLC) level ≥ 10mg/dl (≥ 100mg/l) and an abnormal serum free light chain ratio (\< 0.26, or \> 1.65)
* 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.
* Prior B-cell maturating antigen (BCMA) chimeric antigen receptor (CAR)-T is permitted but at least 6 months must have lapsed from CAR-T exposure
* Prior tumor necrosis factor alpha (TNFα) inhibitor use for a concomitant condition (ex. Rheumatoid arthritis) is permitted but at least 6 months must have lapsed from exposure
* Patients must have hemoglobin ≥ 7g/dL
* Absolute neutrophil count (ANC) ≥ 1000/µL
* Platelets ≥ 50,000/µL
* Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \< 2.5 X the ULN
* Calculated creatinine clearance of ≥ 30ml/min using Modification of Diet in Renal Disease (MDRD) formula
* Patients must have adequate cardiac function as evidenced by:
* Left ventricular ejection fraction ≥ 30%; baseline echocardiography (ECHO) is not required if ECHO was done within the preceding 6 months and patients …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing infliximab as a way to prevent cytokine release syndrome before it even starts during teclistamab or talquetamab treatment — could adding a prophylactic drug like infliximab actually affect how well those bispecific antibodies work against my myeloma?
2Since this trial is Phase 2 and hasn't started recruiting yet, what does that mean for how much safety data will be available when it does open, and how does that uncertainty compare to what's already known about managing CRS with my current treatment options?
3The trial is specifically for relapsed or refractory myeloma — given where I am in my treatment journey, would my doctor consider teclistamab or talquetamab a reasonable next step for me regardless of this trial, and does adding infliximab change that calculation?
4CRS is the main thing this trial is measuring — can you help me understand how serious my personal risk of CRS would be on these bispecific antibodies, and whether a prophylactic approach like this is something that would genuinely matter for my situation?
5Because this trial isn't recruiting yet, how would we find out when it opens, and is there a standard-of-care approach to CRS prevention I could access in the meantime if you and I decide one of these therapies is the right path?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of all-grade cytokine release syndrome (CRS)
Timeframe: From baseline, up to day 28
Trial details
NCT IDNCT07657312
SponsorNaresh Bumma
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center