Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

What this Trial Is About

This research aims to collect long-term follow-up data to understand delayed side effects and the overall long-term safety profile of ciltacabtagene autoleucel cilta-cel, an autologous CAR-T therapy targeting B-cell maturation antigen BCMA in people who have previously received this treatment. The study focuses on participants treated for multiple myeloma and monitors safety concerns that may arise years after treatment. The study involves no new treatment administration. It consists of two phases the first phase covers up to 5 years after the participants last dose of cilta-cel, and the second phase follows from year 6 up to 15 years after that dose. Participants are monitored at least once a year for delayed adverse events, including new or worsening malignancies, neurological disorders, autoimmune conditions, serious infections, and hematologic disorders. During the study, participants undergo safety evaluations such as physical exams, neurological assessments, laboratory tests, and review of adverse events. Researchers will measure outcomes including incidence of serious adverse events, infections, malignancies, and autoimmune disorders over the entire 15-year period. No new treatment is given, and participants will be followed long term to gain knowledge about cilta-cels safety and survival outcomes.

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel