A Clinical Overview of the CARTITUDE-4 Trial for Cilta-Cel CAR T Therapy in Early R/R MM

EP: 1.Overview of Multiple Myeloma

EP: 2.Patient Perspectives: Initial Diagnosis of Multiple Myeloma

EP: 3.Multidisciplinary Approaches in Coordinating Care for CAR T Therapy and Patients With Myeloma

EP: 4.Shared Resources and Patient Education for Multiple Myeloma

EP: 5.R/R Multiple Myeloma: Patient Perspectives and Clinical Guidance Upon Diagnosis

EP: 6.Shared Clinical Decision-Making in CAR T Therapy for R/R MM

EP: 7.Nursing Perspectives on Ensuring Patient Success for CAR T Therapy in R/R MM

EP: 8.Patient Perspectives: Response and Adverse Effects to CAR T in R/R MM

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EP: 9.A Clinical Overview of the CARTITUDE-4 Trial for Cilta-Cel CAR T Therapy in Early R/R MM

EP: 10.Clinical Perspectives in Current and Emerging CAR T Therapies for Early R/R MM

The CARTITUDE-4 clinical trial represents a landmark study that led to FDA approval of CAR T therapy as second-line treatment for R/R MM. This pivotal trial directly compared cilta-cel CAR T therapy against current standard-of-care treatments, including established regimens such as daratumumab combined with pomalidomide and dexamethasone or daratumumab with pomalidomide, bortezomib (Velcade), and dexamethasone. These comparison therapies represent some of the most effective conventional treatments available for patients with R/R MM.

The trial results demonstrated CAR T therapy’s clear superiority across multiple critical end points. Patients who received CAR T achieved significantly higher response rates, complete remission rates, and deep remission rates, including MRD-negative status, compared with patients who received standard care. Durability of response was particularly striking, with patients receiving CAR T maintaining remission years after treatment, whereas those receiving standard care typically experienced disease progression within approximately 18 months. Additionally, CAR T recipients enjoyed treatment-free intervals after their initial therapy period, whereas standard care recipients required continuous ongoing treatment with associated clinic visits and time commitments.

Most significantly, CARTITUDE-4 demonstrated a survival advantage for CAR T therapy, marking the first time any treatment has shown improved overall survival in this patient population. Beyond survival benefits, quality-of-life improvements were substantial for CAR T recipients who, after the initial treatment period, experienced fewer symptoms and could resume normal activities compared with standard care recipients who continued experiencing treatment-related adverse effects and lifestyle disruptions from ongoing therapy requirements. This combination of superior efficacy, improved quality of life, treatment-free periods, and, most importantly, prolonged survival has established CAR T therapy as a transformative treatment option that fundamentally changes the treatment paradigm for patients with early R/R MM.