Infliximab for Cytokine Release Syndrome in Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Naresh Bumma, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with multiple myeloma that has come back or not responded to treatment, who have had at least 4 prior therapies. Participants need good organ function, no active infections like hepatitis B or tuberculosis, and must use reliable birth control if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive infliximab IV on day 1, followed by teclistamab or talquetamab SC on days 1, 3, 5, 15, 22, and 28
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Infliximab
- Talquetamab
- Teclistamab
Trial Overview
The study tests whether infliximab can help prevent cytokine release syndrome (CRS) in patients receiving teclistamab or talquetamab for relapsed/refractory multiple myeloma. Patients will also undergo various scans and lab tests as part of the trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive infliximab IV on day 1, two to four hours prior to treatment with standard of care teclistamab or talquetamab. Patients then receive teclistamab SC or talquetamab SC per treating physician discretion. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and may undergo an x-ray or PET-CT scan during screening and also blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Naresh Bumma
Lead Sponsor
Janssen Research & Development, LLC
Industry Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry Sponsor
Joaquin Duato
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.