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In CARTITUDE-4, ciltacabtagene autoleucel (cilta-cel) significantly improved progression-free survival (primary endpoint; previously reported) versus standard of care in patients with relapsed, lenalidomide-refractory multiple myeloma. We report here patient-reported outcomes.

•Real-world patients with lenalidomide-refractory MM and 1 to 3 prior LOT progress rapidly through therapies.•Outcomes remain suboptimal, despite greater use of newer combination therapies, highlighting the need for early use of novel treatments.

Cilta-cel, a BCMA-targeting CAR-T cell therapy, has shown high rates of deep and durable response in patients (pts) with relapsed/refractory multiple myeloma (RRMM). We describe presentation and management of cranial neuropathy (CNP) in pts treated with cilta-cel across the CARTITUDE-1, -2, and -4 trials.

CARTITUDE-4 (NCT04181827) is a phase 3 trial comparing ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen chimeric antigen receptor-T cell (CAR-T) therapy, with standard of care (SOC; pomalidomide, bortezomib, and dexamethasone [PVd] or daratumumab, pomalidomide, and dexamethasone [DPd]) in patients (pts) with lenalidomide (len)-refractory multiple myeloma (MM). Pts in the cilta-cel arm had significantly improved progression-free survival (PFS), higher rates of ≥complete response (CR), and higher overall response rate (ORR) versus SOC in the intent-to-treat (ITT) set.

Introduction:Cilta-cel is a dual-binding, BCMA-targeting CAR-T cell therapy that has shown high rates of deep and durable response in patients (pts) with relapsed/refractory multiple myeloma (RRMM), and significantly prolonged PFS vs SOC in pts with lenalidomide-refractory MM after 1-3 prior lines of therapy (LOT; HR, 0.26) in the phase 3 CARTITUDE-4 trial. CAR-T therapies are associated with AEs related to immune activation, including neurologic toxicities (Gonzalez Castro. Neuro-Oncol Pract.2020). Here, we describe the clinical experience with presentation and management of cranial neuropathy (CNP) in pts treated with cilta-cel in the CARTITUDE-1, CARTITUDE-2 Cohorts A, B, and C, and CARTITUDE-4 studies.

Introduction:The phase 3 CARTITUDE-4 trial (NCT04181827) in patients with multiple myeloma (MM) after 1-3 lines of therapy compared ciltacabtagene autoleucel (cilta-cel) with standard of care (SOC; pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone). In the primary analysis, a single cilta-cel infusion significantly improved progression-free survival (hazard ratio [HR], 0.26; P<0.0001) and increased the rate and depth of response vs SOC. Here, we present adjusted comparisons of patient-reported outcomes (PROs) from patients randomized to cilta-cel vs SOC in CARTITUDE-4.

Introduction:CARTITUDE-4 (NCT04181827) is a randomized, phase 3 trial comparing ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, with standard of care (SOC; pomalidomide, bortezomib, and dexamethasone [PVd] or daratumumab, pomalidomide, and dexamethasone [DPd]) in patients (pts) with lenalidomide (len)-refractory multiple myeloma (MM). The trial recently showed that pts in the cilta-cel arm experienced significantly improved progression-free survival (PFS) vs SOC (HR, 0.26; P<0.0001) and a significantly higher rate of complete response (CR) or better and overall response rate (ORR) in the intent-to-treat (ITT) set (San-Miguel et al, New Engl J Med2023). We report efficacy and safety in pts who received cilta-cel as study treatment (‘as-treated’ set) in the experimental (cilta-cel) arm of the study.

Introduction:Rareevents of T-cell lymphoma (TCL) derived from CAR-T cells (2 cases) have been reported in patients receiving nonviral piggyBac transposon-based CAR-T therapy (Micklethwaite et al, Blood, 2021). Ciltacabtagene autoleucel (cilta-cel) is an anti-BCMA CAR-T therapy produced via conventional lentiviral transduction. In the randomized, phase 3 CARTITUDE-4 study (NCT04181827), cilta-cel significantly improved PFS (HR=0.26) vs standard of care in lenalidomide-refractory patients with multiple myeloma and 1-3 prior lines of therapy. We present the clinicogenomic characterization of a CARTITUDE-4 patient who developed a CAR+ TCL post cilta-cel.