Overview of the CARTITUDE-4 Trial: Cilta-Cel in Multiple Myeloma

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EP: 1.Overview of the CARTITUDE-4 Trial: Cilta-Cel in Multiple Myeloma

EP: 2.Key Findings From the CARTITUDE-4 Trial of Cilta-Cel in Multiple Myeloma

EP: 3.Evaluating Cilta-Cel’s Efficacy in the CARTITUDE-4 Trial

EP: 4.Key Takeaways From the CARTITUDE-4 Trial in Multiple Myeloma

Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, provides an overview of the CARTITUDE-4 trial (NCT04181827), including its methods, design, and inclusion criteria.

In CARTITUDE-4, treatment with the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel (cilta-cel; Carvykti) was evaluated when used as a treatment for patients with lenalidomide (Revlimid)-refractory multiple myeloma and who had received at least 1 prior line of therapy.

According to updated results from the phase 3 CARTITUDE-4 trial presented at the 2024 International Myeloma Society Annual Meeting, cilta-cel reduced the risk of death by 45% vs standard of care (SOC) in this patient population.

Transcription:

0:09 | CARTITUDE-4 is actually 1 of the first 2 randomized studies to compare CAR T against standard of care in patients with early relapse multiple myeloma. Specifically, if you look at the CARTITUDE-4 trial, it is a phase 3, randomized trial comparing ciltacabtagene autoleucel or cilta-cel vs standard of care regimens, which are mainly 2, pomalidomide [Pomalyst], bortezomib [Velcade], and dexamethasone [PVd], or daratumumab [Darzalex] plus pomalidomide and dexamethasone [DPd], in patients with 1 to 3 prior lines of therapy and were lenalidomide-refractory.

0:42 | The primary end point of the study was progressive-free survival. In the study, the patients were randomized 1:1 to receive either cilta-cel or a standard of care, which is either PVd or DPd, based on physician choice. Patients who are randomized to cilta-cel receive bridging therapy, which was either PVd or DPd, again, based on physician’s choice, before receiving the cilta-cel. Patients in the standard of care arm continued the treatment until progression, whereas in the cilta-cel arm, [patients] received 1 infusion of cilta-cel and were followed up.

1:16 | There are a number of secondary end points that were also assessed in the study, including overall survival, response rate, including deep response rate, and time to symptom worsening and [minimal residual disease] negativity rates.

REFERENCE:

Mateos M-V, San-Miguel J, Dhakal, et al. Overall survival (OS) with ciltacabtagene autoleucel (Cilta-cel) versus standard of care (SoC) in lenalidomide (Len)-refractory multiple myeloma (MM): Phase 3 CARTITUDE-4 study update. Presented at: 2024 International Myeloma Society Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil. Abstract OA – 65.