Cytokine release syndrome Trials in Disease

Study on Dasatinib for Preventing Side Effects in Patients with Relapsed or Refractory Multiple Myeloma Receiving Idecabtagene Vicleucel Therapy

This clinical trial is being conducted in Germany and focuses on preventing cytokine release syndrome in patients with relapsed or treatment-resistant multiple myeloma who are receiving a specialized cancer treatment called CAR-T cell therapy.

Main inclusion criteria: The trial is open to adults aged 18 years or older who have a confirmed diagnosis of relapsed or refractory multiple myeloma and are eligible for CAR-T cell therapy with idecabtagene vicleucel. Participants must be able to understand and sign the consent form before any study procedures begin. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods during the study and for one year after treatment. Men must also agree to use appropriate contraceptive measures during sexual contact throughout the study period.

Main exclusion criteria: Patients cannot participate if they have recent infections that are not fully resolved, a history of severe allergic reactions to similar medications, or if they are currently pregnant or breastfeeding. Those with significant heart problems such as uncontrolled high blood pressure or heart failure, severe liver or kidney disease, or who are taking medications that might interact negatively with the study drug are also excluded. Additionally, patients who have participated in another clinical trial within the last 30 days, have a history of certain types of cancer that are not in remission, or have a history of drug or alcohol abuse within the past year cannot join the study.

Focus and goal: The trial aims to evaluate whether dasatinib can safely and effectively prevent cytokine release syndrome in patients receiving idecabtagene vicleucel therapy. Cytokine release syndrome occurs when the immune system becomes overly active during CAR-T cell therapy, releasing large amounts of signaling molecules called cytokines into the bloodstream. This can cause symptoms ranging from fever and fatigue to more serious complications affecting multiple organs. The study will monitor participants from the day of infusion through day 30 to track the frequency and severity of side effects, with continued follow-up extending to 360 days to assess long-term health outcomes and treatment response.

Investigational drugs: The trial tests two main medications. Idecabtagene vicleucel is a CAR-T cell therapy where a patient's own immune cells are modified to better recognize and attack cancer cells, then infused back into the patient to treat multiple myeloma. Dasatinib is given orally as 140 mg film-coated tablets to help prevent cytokine release syndrome. Dasatinib is a tyrosine kinase inhibitor, meaning it blocks certain proteins involved in cell growth and survival, thereby reducing inflammation and immune response. While dasatinib is primarily used for treating certain types of leukemia, this trial is investigating its potential to manage side effects associated with CAR-T cell therapy.