Idecabtagene vicleucel (ide-cel)

A prospective randomized trial (NCT03651128) included 386 patients with relapsed or refractory myeloma after two to four prior lines of treatment who also had lenalidomide-refractory disease. Patients received either CAR T-cell therapy with ide-cel or one of five standard alternative regimens.[46,47]Based on this trial, the FDA approved ide-cel for patients with (1) relapsed or refractory myeloma after at least two lines of therapy AND (2) lenalidomide-refractory disease.

A prospective randomized trial (NCT03651128) included 386 patients with relapsed or refractory myeloma after two to four prior lines of treatment who also had lenalidomide-refractory disease. Patients received either CAR T-cell therapy with ide-cel or one of five standard alternative regimens.[46,47]Based on this trial, the FDA approved ide-cel for patients with (1) relapsed or refractory myeloma after at least two lines of therapy AND (2) lenalidomide-refractory disease.

With a median follow-up of 30.9 months, the median PFS was 13.8 months in the ide-cel group versus 4.4 months in the standard-regimen group (HR, 0.49; 95% CI, 0.38–0.63; P < .0001).[47][Level of evidence B1]

A prospective randomized trial (NCT03651128) included 386 patients with relapsed or refractory myeloma after two to four prior lines of treatment who also had lenalidomide-refractory disease. Patients received either CAR T-cell therapy with ide-cel or one of five standard alternative regimens.[46,47]Based on this trial, the FDA approved ide-cel for patients with (1) relapsed or refractory myeloma after at least two lines of therapy AND (2) lenalidomide-refractory disease.

The overall and complete response rates were higher in patients who received ide-cel (71% and 39%, respectively) than in patients who received the standard regimens (42% and 5%, respectively).

A prospective randomized trial (NCT03651128) included 386 patients with relapsed or refractory myeloma after two to four prior lines of treatment who also had lenalidomide-refractory disease. Patients received either CAR T-cell therapy with ide-cel or one of five standard alternative regimens.[46,47]Based on this trial, the FDA approved ide-cel for patients with (1) relapsed or refractory myeloma after at least two lines of therapy AND (2) lenalidomide-refractory disease.

Grade 3 or 4 adverse events occurred in 93% of patients who received ide-cel and 75% who received a standard regimen. Ide-cel was associated with cytokine-release syndrome in 88% of patients (grade 3 or higher in 5% of patients) and with neurological symptoms in 15% of patients (grade 3 or higher in 3% of patients).