Ide-cel vs. Standard Regimens in Refractory Multiple Myeloma
Patient-Reported Outcomes of the KarMMa-3 Trial
Dr. Michel Delforge discusses the results of the "Patient-Reported Outcomes in Triple Class-Exposed Relapsed Refractory Multiple Myeloma Patients in the KarMMa-3 Trial" poster. The KarMM-3 study is a phase 3 randomized control trial that enrolled patients with relapsed refractory multiple myeloma who were triple class-exposed and had received two to four prior regimens. The study compared the patient-reported outcomes (PROs) of patients treated with ide-cel (an investigational BCMA-targeting CAR T-cell therapy) versus standard regimens.
The study found that ide-cel showed significant and clinically meaningful improvements in health-related quality of life compared to standard regimens. Patients treated with ide-cel experienced rapid and sustained improvements in global health status, physical function, cognitive functioning, fatigue, pain, and myeloma-related disease symptoms. Side effects of treatment were temporary and improved over time. The EQ-5D-5L health utility index also showed improvement with ide-cel treatment.
The baseline PRO results were comparable between the two treatment arms and worse for both arms than in the European general population. However, ide-cel demonstrated greater improvements in PROs compared to standard regimens, exceeding pre-specified thresholds for most domains. This makes ide-cel the first chimeric antigen receptor T-cell therapy for relapsed refractory multiple myeloma to demonstrate improved PROs in a phase 3 randomized control study.
- The KarMMa-3 trial is an open-label phase 3 randomized control trial for relapsed refractory multiple myeloma patients who were triple class-exposed and had received two to four prior regimens.
- Ide-cel, a BCMA-targeting CAR T-cell therapy, showed significant and clinically meaningful improvements in patient-reported outcomes (PROs) compared to standard regimens.
- Patients treated with ide-cel experienced rapid and sustained improvements in global health status, physical function, cognitive functioning, fatigue, pain, and myeloma-related disease symptoms.
- Side effects of ide-cel treatment were temporary and improved over time.
- The EQ-5D-5L health utility index demonstrated improvement with ide-cel treatment.
- Baseline PRO results were worse for both treatment arms compared to the European general population.
- Ide-cel is the first CAR T-cell therapy for relapsed refractory multiple myeloma to demonstrate improved PROs in a phase 3 randomized control study.
Authors:
Michel Delforge, Krina K. Patel, Laurie Eliason, Devender Dhanda, Ling Shi, Shien Guo, Thomas Marshall, Bertrand Arnulf, Michele Cavo, Ajay K. Nooka, Salomon Manier, Natalie Scott Callander, Sergio Giralt, Hermann Einsele, Sikander Ailawadhi, Mihaela Popa McKiver, Mark Cook, Paula Rodríguez-Otero
Doctor Bio:
Michel Delforge, MD, PhD, is a physician at the Department of Hematology of University Hospital Leuven, Leuven, Belgium. Prof. Delforge received his medical degree from the Catholic University of Leuven, and completed his residency in Internal Medicine at the University Hospital Gasthuisberg, Leuven and Imelda Ziekenhuis, Bonheiden. In 1998, he obtained a PhD from the Catholic University of Leuven. Besides being a physician, Prof. Delforge is also a professor of medicine and the clinical Head of Hematology at University Hospital Leuven.
