Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma
Naresh Bumma
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.
Description
PRIMARY OBJECTIVE: I. To determine the efficacy of infliximab as CRS prophylaxis for patients with relapsed/refractory multiple myeloma (RRMM) treated with teclistamab or talquetamab therapy. SECONDARY OBJECTIVES: I. To estimate the incidence of grade ≥ 3 CRS within cycle 1 (28 days). II. To estimate the incidence of all-grade and grade ≥ 3 neurologic toxicity (including Immune effector cell-associated neurotoxicity syndrome \[ICANS\]) within cycle 1 (28 days). III. To estimate the incidence of grade ≥ 3 infection within cycle 1 (28 days). IV. To estimate the incidence of grade ≥ 3 anemia…