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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07657312.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Naresh Bumma
Phone: 614-293-6307
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 within cycle 1 (28 days).
V. To estimate the incidence of grade ≥3 neutropenia within cycle 1 (28 days).
VI. To estimate the incidence of grade ≥ 3 thrombocytopenia within cycle 1 (28 days).
VII. To determine the overall response rate (ORR) (per International Myeloma Working Group [IMWG] criteria).
EXPLORATORY OBJECTIVE:
I. Provide a descriptive summary of changes in plasma cytokine concentrations in patients treated with teclistamab or talquetamab with prophylactic infliximab.
OUTLINE:
Patients receive infliximab intravenously (IV) on day 1, two to four hours prior to treatment with standard of care teclistamab or talquetamab. Patients then receive teclistamab subcutaneously (SC) or talquetamab SC on days 1, 3, 5, 15, 22, and 28 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 positron emission tomography (PET)-computed tomography (CT) scan during screening and also blood sample collection throughout the study.
After completion of study treatment, patients are followed up at day 28.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorNaresh Bumma
