Multinational phase 3 trial of idecabtagene vicleucel versus standard regimes for relapsed or refractory multiple myeloma

Survival is poor among patients with triple-class-exposed relapsed and refractory multiple myeloma (RRMM). Idecabtagene vicleucel (ide-cel) is a BCMA-directed CAR T-cell therapy. A multinational phase 3 trial randomized adult patients with RRMM who had received two to four regimens previously to ide-cel or one of five standard regimens. The primary end point was progression-free survival. The median PFS was 13.3 months in the ide-cel group versus 4.4 months in the standard-regimen group (HR 0.49; p<0.001). A response occurred in 71% versus 42%; a complete response in 39% versus 5%. Adverse events of grade 3 or 4 occurred in 93% of the patients in the ide-cell group and in 75% of the patients in the standard-regimen group.