6/28/23, 11:53 PM KarMMa-3 Pathway Feedback Search Clinical Topics Home Studies KarMMa-3 KarMMa-3 Disease Multiple myeloma Trial question What is the role of idecabtagene vicleucel in patients with relapsed and refractory multiple myeloma? Study design Multi-center Open label RCT Population Characteristics of study participants 39.0% female N = 386 61.0% male 386 patients (151 female, 235 male) Inclusion criteria: adults with triple-class-exposed relapsed and refractory multiple myeloma who had received 2-4 regimens previously Key exclusion criteria: nonsecretory multiple myeloma; inadequate pulmonary function; active history of plasma cell leukemia; known CNS involvement with myeloma Interventions N=254 ide-cel (dose range, 150 10 to 450 10 chimeric antigen receptor-positive T cells) N=132 standard regimen (either one of the regimens including daratumumab, pomalidomide, and dexamethasone; or daratumumab, bortezomib, and dexamethasone; or ixazomib, lenalidomide, and dexamethasone; or carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone) Primary outcome https://web.pathway.md/studies/recq6SB47vqyvBxnJ 1/2 6/28/23, 11:53 PM KarMMa-3 Pathway Median progression-free survival 13.3 months 13.3 10.0 months 6.7 months 4.4 3.3 months Significant increase 0.0 months Ide-cel Standard regimen Significant increase in median progression-free survival (13.3 months vs. 4.4 months; AD 8.9 months, 95% CI 3.62 to 14.18) Secondary outcomes Significant increase in overall response (71% vs. 42%; AD 29%, 95% CI 11.79 to 46.21) Safety outcomes No significant difference in any adverse events. Significant differences in neutropenia (78% vs 44%), anemia (66% vs. 36%), thrombocytopenia (54% vs. 29%). Conclusion In adults with triple-class-exposed relapsed and refractory multiple myeloma who had received 2-4 regimens previously, ide-cel was superior to standard regimen with respect to median progression-free survival. Reference Paula Rodriguez-Otero, Sikander Ailawadhi, Bertrand Arnulf et al. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Mar 16;388(11):1002-1014. Open reference URL https://web.pathway.md/studies/recq6SB47vqyvBxnJ 2/2