Outpatient Versus Inpatient Administration of Ciltacabtagene Autoleucel in Multiple Myeloma: A Systematic Review of Clinical, Economic, and Humanistic Outcomes

Background/Objectives: Ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma is typically administered inpatient (IP) to monitor for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Because cilta-cel toxicities are typically delayed, outpatient (OP) administration (infusion and early monitoring) is being explored. We synthesized available evidence on OP and IP administration. Methods: MEDLINE, Embase, and Cochrane Library were searched from inception to August 5, 2025, supplemented by conference and gray literature searches. Eligible studies of adults with multiple myeloma receiving cilta-cel reported efficacy, safety, resource use, costs, and/or quality-of-life outcomes; findings were synthesized descriptively due to heterogeneity. Results: Seventy-four records (56 studies) were included; 90 patients received OP cilta-cel. OP clinical evidence (primarily three real-world studies) showed high response rates (ORR: 95%; median follow-up 4. 6 months) and reported 1-year PFS and OS of 86% and 96%. In IP studies, median ORR was 91%, with median 1-year PFS 76% and median 1-year OS 85%. Any-grade CRS and ICANS occurred in 79–84% and 17–22% of OP patients (largely low grade) ; IP cohorts reported a median ICANS incidence of 17% (range 5–23%). Most OP patients were later hospitalized (86–93%), but stays were shorter (median 4–6. 5 days) than in an IP cohort (median 19 days). Comparisons were unadjusted and may reflect selection differences. One modeling-based economic analysis estimated savings of ~19, 000 per OP-treated patient. Conclusions: OP cilta-cel appears feasible for selected patients and may reduce costs without compromising outcomes. Findings are descriptive and hypothesis-generating and prospective multicenter studies are needed to define long-term safety, durability, quality of life, and cost-effectiveness.