Binod Dhakal, MD, Associate Professor at Medical College of Wisconsin discusses results of the phase 3 multiple myeloma clincial trial. This trial compared Ciltacabtagene autoleucel to standard of care in patients with lenalidomide-refractory multiple myeloma.

 

 

The New England Journal of Medicine recently published the multiple myeloma trial results.

Ciltacabtagene autoleucel (cilta-cel) is a B-cell maturation antigen (BCMA)–directed CAR-T cell therapy. Currently, it indicates the treatment of adults with relapsed multiple myeloma after undergoing four or more prior therapy lines. These include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

As explained by Dr. Dhakal, the study was a phase 3, randomized, open-label trial. Patients with lenalidomide-refractory multiple myeloma received cilta-cel or the physician’s choice of effective standard care. All the patients had received one to three previous lines of treatment. 

Study:

At a median follow-up of 15.9 months, the median progression-free survival was not reached in the cilta-cel group compared to 11.8 months in the standard-care group. Progression-free survival at 12 months was 75.9% in the cilta-cel group vs 48.6% in the standard-care group. The study also observed an overall response of 84.6% in the citla-cel group vs 67.3% in the standard-care group.The citla-cel group exhibited a complete response or better of 73.1%, whereas the standard-care group showed only 21.8%. Among the patients who received cilta-cel, 76.1% had cytokine release syndrome (grade 3 or 4, 1.1%; no grade 5), and 4.5% had immune effector cell–associated neurotoxicity syndrome (all grade 1 or 2), 9.1% had cranial nerve palsy (grade 2, 8.0%; grade 3, 1.1%), and 2.8% had CAR-T–related peripheral neuropathy (grade 1 or 2, 2.3%; grade 3, 0.6%).

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