Potential for Shorter Monitoring Period for Patients With R/R MM Following CAR-T Therapy

According to results of a large multicenter analysis, a flexible, shorter monitoring period may be reasonable among patients with relapsed-refractory (R/R) multiple myeloma (MM) who had received B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy due to an observed low risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed after 2 weeks following infusion

“BCMA-directed CAR-T therapies, including idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), have transformed the treatment landscape for relapsed/refractory multiple myeloma, offering remarkable efficacy with hallmark toxicity risks of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome,” stated lead study author William Wesson, MD, University of Kansas Cancer Center, Westwood, Kansas, and colleagues.

It was noted by investigators that the US Food and Drug Administration (FDA) currently mandates a 4-week monitoring period at the treatment center as part of a Risk Evaluation and Mitigation Strategy (REMS) to monitor and manage these toxicities. This retrospective study examined 129 ide-cel and cilta-cel recipients that received CAR-T infusions from May 2021 to June 2023 across 4 academic centers. Infusion and toxicities were managed per institutional guidelines as directed by previously published guidelines.

Results demonstrated that, while differences were noted in the incidence and duration of CRS/ICANS between ide-cel and cilta-cel, late-onset CRS and ICANS were rare after 2 weeks following infusion (0% and 1.6%, respectively). Additionally, non-relapse mortality (NRM) was driven by hemophagocytic lymphohistiocytosis and infections in the early follow-up period (1.1% until Day 29), then by infections through 3 months post-infusion (1.2%).

It was noted that 25% of patients had to relocate for 4 weeks due to distance from the treatment center.

“With the low risk of CRS and ICANS after 2 weeks, a flexible shorter monitoring period may be reasonable, emphasizing collaboration with referring oncologists to improve NRM,” concluded Dr Wesson and colleagues.

Source:

Wesson W, Dima D, Suleman N, et al. Timing of toxicities and non-relapse mortality following CAR T therapy in myeloma. Trans and Cell Ther. Published online June 11, 2024. doi: 10.1016/j.jtct.2024.06.012