The New England Journal of MedicineCilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma

75.9% of the patients in the cilta-cel group achieved progression-free survival at 12 months, in comparison to 48.6% in the standard-care group.

In a significant phase 3 trial for the treatment of lenalidomide-refractory multiple myeloma, researchers have studied the effects of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)–directed CAR T-cell therapy. The findings shed light on the efficacy of cilta-cel in earlier treatment lines, compared to standard care.

Study Design:

• Phase: 3, randomized, open-label trial
• Participants: 419 patients with lenalidomide-refractory multiple myeloma
• Treatment Groups: 208 to receive cilta-cel, 211 to receive standard care
• Previous Lines of Treatment: One to three
• Primary Outcome: Progression-free survival
• Follow-up Duration: Median follow-up of 15.9 months (range, 0.1 to 27.3)

Key Findings:

• Progression-Free Survival: Median not reached in cilta-cel group, 11.8 months in standard-care group (hazard ratio, 0.26; 95% CI, 0.18 to 0.38; P<0.001)
• 12-Month Progression-Free Survival: 75.9% in cilta-cel group, 48.6% in standard-care group
• Overall Response: 84.6% vs. 67.3%; complete response or better 73.1% vs. 21.8%; absence of minimal residual disease 60.6% vs. 15.6%
• Death from Any Cause: 39 vs. 46 patients (hazard ratio, 0.78; 95% CI, 0.5 to 1.2)
• Adverse Events: Most reported grade 3 or 4; specific adverse events detailed in cilta-cel group

Conclusion:

• A single infusion of cilta-cel resulted in a reduced risk of disease progression or death when compared to standard care in patients with lenalidomide-refractory multiple myeloma who had received one to three previous therapies. This finding underscores the potential value of cilta-cel as an effective treatment option in this patient population.

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Did You Know?
Multiple myeloma is the second most common hematological malignancy, and despite advances in treatment, it remains incurable. CAR T-cell therapy represents a promising therapeutic approach, with several ongoing clinical trials targeting different antigens, such as BCMA, indicating a new frontier in the treatment of this complex disease.