Plain language summary of the long-term (5 or more years) outcomes in the CARTITUDE-1 trial of ciltacabtagene autoleucel in people with relapsed or refractory multiple myeloma

Plain Language SummaryWhat is this summary about?This is a summary of the long-term results in a clinical study called CARTITUDE-1. This trial tested the anti-cancer chimeric antigen receptor-T cell (CAR-T) therapy ciltacabtagene autoleucel, or cilta-cel, in people with multiple myeloma, a cancer that affects a specific type of blood cells called plasma cells. Participants in CARTITUDE-1 had multiple myeloma that returned or did not improve after 3 or more anti-cancer treatments, which is known as relapsed or refractory multiple myeloma. People with relapsed or refractory multiple myeloma who have received many previous anti-cancer treatments have short life expectancy of a median (calculated as the middle number when numbers are listed from shortest to longest time) of approximately 1 year after their most recent treatment.How was the study in this summary conducted?In CARTITUDE-1, 97 participants were treated with a single dose of cilta-cel. After approximately 3 years, the CARTITUDE-1 study was considered completed and participants were able to join another study called CARTinue, where physicians would continue to monitor for side effects and whether participants continued to respond to cilta-cel for 15 years.What are the key takeaways?Participants in CARTITUDE-1 lived for a median of 60.7 months after treatment with cilta-cel. Five years or more after treatment with cilta-cel, 32 of 97 participants (33%) were still alive without treatment and without signs of cancer returning, known as relapse. Factors such as age, sex, having more severe or higher-risk multiple myeloma, and the number of other anti-myeloma drugs participants had received before being treated with cilta-cel were not different between participants who were still responding to cilta-cel for 5 or more years compared with participants whose cancer came back within 5 years. In contrast, having healthier stronger immune cells to fight cancer was a distinguishing factor between the 2 groups. In a group of 12 participants who had specialized testing to see if researchers could detect very low levels of multiple myeloma, which is known as minimal-residual disease, none of the participants had any traces of cancer detected. The long-term side effects reported in participants treated with cilta-cel were similar to what researchers expected based on previous reports from CARTITUDE-1 and other studies of cilta-cel.What were the main conclusions reported by the researchers?Overall, a third of participants in CARTITUDE-1 were still alive without any signs of relapse and without additional anti-myeloma treatment over 5 years after treatment with cilta-cel. These results show that cilta-cel may provide a potential long-lasting remission from multiple myeloma in some people with relapsed or refractory multiple myeloma.Clinical trial number: NCT03548207