About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients with Waldenstrom macroglobulinemia, primary amyloid light chain (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
Live vaccines should not be given concurrently with infliximab. Vaccination with live virus vaccines is not recommended for at least 4 weeks prior to the start of treatment, during treatment and least 4 weeks after treatment
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Biopsy
- Computed Tomography
- Infliximab
- Positron Emission Tomography
- Talquetamab
- Teclistamab
- X-Ray Imaging
Treatment groups
Sponsors and collaborators
Naresh Bumma
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Janssen Research & Development, LLC
Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator