使用可穿戴设备和细胞因子谱检测多发性骨髓瘤 CAR-T 治疗后的细胞因子释放综合征

BACKGROUNDChimeric antigen receptor T-cell (CAR-T) therapies have revolutionized treatment for relapsed/refractory multiple myeloma (RRMM).

However, cytokine release syndrome (CRS), a common and potentially severe complication, requires inpatient monitoring, limiting access and increasing costs. Wearable devices could support outpatient CAR-T delivery, but feasibility for CRS detection versus standard care remains unproven. METHODSWe conducted a prospective, single-center observational pilot study to assess the feasibility of using wearable devices for monitoring vital signs and detecting CRS. Thirty patients receiving idecabtagene vicleucel (ide-cel) or ciltacabtagene autoleucel (cilta-cel) were enrolled; 25 with sufficient monitoring data were evaluable. Sensors collected skin and axillary temperature, oxygen saturation, respiratory and heart rate, and motion. Peripheral blood cytokines were analyzed pre- and postinfusion using a multiplex proteomic platform.

The primary outcome was feasibility, assessed by CRS detection sensitivity and specificity; secondary outcomes included adherence, lead time, and performance of models integrating wearable and cytokine data. RESULTSCRS occurred in 20 of 25 patients. The best-performing wearable model detected 18 or 20 CRS episodes with a sensitivity of 0. 72 (mean 0. 75; 95% CI 0. 60-0. 91) and a specificity of 0. 80 (mean 0. 76; 95% CI 0. 68-0.

84), and a median lead time of 7:00 hours before nursing recognition. Median adherence during high-risk periods was 71%. Cytokine changes paralleled temperature elevations, and IFN- emerged as a consistent biomarker. CONCLUSIONWearable devices are feasible for early CRS detection and may support outpatient CAR-T care. Larger outpatient studies are warranted. TRIAL REGISTRATIONThis study did not meet the criteria for ClinicalTrials. gov registration.