CAR-T therapy is feasible, relatively safe, and effective in carefully selected HD-dependent MM patients, supporting expanded eligibility with appropriate dose modification.
Hemodialysis-dependent multiple myeloma patients represented a small but identifiable subset of CAR-T recipients at two U.S. centers.
The HD-dependent CAR-T patient cohort was disproportionately Black and female with a median age of 63 years.
Two BCMA-directed CAR-T products were used, with lymphodepletion regimens split between bendamustine and dose-reduced fludarabine/cyclophosphamide.
Cytokine release syndrome (CRS) occurred in 37.5% of HD patients, all Grade 1, which was substantially lower than rates observed in pivotal trials.
All 7 evaluable patients achieved neutrophil recovery by Day 30 following CAR-T infusion.
One patient developed Grade 4 immune effector cell-associated neurotoxicity syndrome (ICANS) and died from fungal pneumonia.
Median progression-free survival was 17.5 months and median overall survival was not reached in the HD-dependent cohort.
HD-dependent MM patients have been excluded from all pivotal trials of BCMA-directed CAR-T therapy, creating a critical evidence gap in a population disproportionately represented by Black patients.
This research suggests that a specific group of multiple myeloma patients — those who depend on hemodialysis (kidney dialysis) due to end-stage kidney disease — can safely receive a cutting-edge cancer treatment called CAR-T cell therapy, even though they have been excluded from all major clinical trials of this treatment. The study looked at 8 hemodialysis-dependent patients out of 284 total CAR-T recipients at two U.S. cancer centers. Notably, 75% of these patients were Black, reflecting the well-known disparity in kidney disease burden in the Black community. Patients received modified treatment regimens, and outcomes were encouraging: a dangerous side effect called cytokine release syndrome occurred in only 37.5% of patients and was mild (Grade 1) in all cases — far lower than the 76–95% rates seen in pivotal trials. All evaluable patients recovered adequate blood cell counts within 30 days, median progression-free survival was 17.5 months, and median overall survival had not yet been reached. One patient with pre-existing severe blood count problems before treatment developed serious neurological side effects and died from a fungal lung infection, accounting for a treatment-related mortality rate of 12.5%. This research matters because it begins to fill a significant gap in medical evidence. Historically, patients requiring dialysis have been left out of clinical trials for CAR-T therapy, meaning doctors had little guidance on whether and how to offer this potentially life-saving treatment to them. This study suggests that with careful patient selection and dose adjustments to the preparatory chemotherapy regimen, hemodialysis-dependent patients can benefit from CAR-T therapy in ways that are comparable to the broader trial populations. Given that this excluded group is disproportionately Black — a population already facing disparities in both cancer outcomes and kidney disease — the findings have important implications for health equity and call for reconsidering trial eligibility criteria to include this underserved group.
Zolotov E, Mody R, Doucette K, Chappell A, Accolatse-Mati C, Parmar H, et al.. (2026). Overcoming Trial Exclusion: A Multicenter Analysis of Hemodialysis Multiple Myeloma Patients Who Underwent BCMA-Directed CAR-T Therapy.. Current oncology (Toronto, Ont.). https://doi.org/10.3390/curroncol33080475