As reported in the Journal of Clinical Oncology, Gagelmann et al have developed a predictive model (Myeloma CAR-T Relapse [MyCARe] model) for outcomes after B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory multiple myeloma.
Study Details
The retrospective study included 136 European patients (training cohort) and 133 U.S. patients (validation cohort) who received BCMA-directed CAR T cells.
Key Findings
The overall response rate was approximately 87% in both cohorts, with complete responses observed in 48% of the European cohort and 49% of the U.S. cohort. Median time to relapse after CAR T-cell treatment was 5 months in both cohorts; relapse at up to 5 months from infusion was associated with poor overall survival, with a 12-month overall survival rate of 30% in the European cohort and 14% in the U.S. cohort.
In the European cohort, the presence of extramedullary disease or plasma cell leukemia, refractoriness to lenalidomide, high-risk cytogenetics, and increased ferritin at the time of lymphodepletion were independent predictors of early relapse or disease progression. Each factor was assigned 1 point in the MyCARe model: scores of 0–1 indicated low risk, 2–3 indicated intermediate risk, and 4 indicated high risk. The model was significantly associated with a 5-month incidence of relapse or disease progression (P < .001), with rates of 7% for low-risk patients, 27% for intermediate-risk patients, and 53% for high-risk patients. The model was validated in the U.S. cohort.
In both cohorts, the model had significant prognostic ability for progression-free survival and overall survival, in addition to relapse risk.
The investigators concluded: “Outcomes of patients with relapsed/refractory multiple myeloma after CAR [T-cell therapy] are comparable between Europe and the United States. The MyCARe model may facilitate optimal timing of CAR T cells in patient-specific subgroups.”
Nico Gagelmann, MD, of the University Medical Center Hamburg-Eppendorf, Germany, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Instituto de Salud Carlos III and others. For full disclosures of the study authors, visit jamanetwork.com.
