Can baseline cytomegalovirus IgG titers predict cytomegalovirus reactivation after ide-cel therapy?

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Chimeric antigen receptor T-cell (CAR-T) therapy is an effective treatment modality for patients with relapsed or refractory multiple myeloma following triple-class exposure.[1][2][3][4] Idecabtagene vicleucel (ide-cel), which is a CAR-T therapy targeting B-cell maturation antigen, 1 demonstrates superior outcomes compared to that of conventional treatment options.5 However, CAR-T therapy is associated with complications, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome, prolonged cytopenia, and hypogammaglobulinemia, 6 which significantly affect treatment outcomes.Beyond CRS and immune effector cell-associated neurotoxicity syndrome, infectious complications, particularly cytomegalovirus (CMV) reactivation, remain a major concern influencing CAR-T therapy outcomes.[7][8][9] Our institution previously reported a 6-month cumulative incidence of 9.2% for CMV retinitis following ide-cel infusion 10 with CMV reactivation exclusively observed in CMV-seropositive patients.This study aimed to stratify the risk of CMV reactivation in CMV-seropositive individuals by examining the predictive value of baseline CMV immunoglobulin G (IgG) titers before CAR-T therapy.In this retrospective, noninterventional cohort study, electronic medical records from patients with multiple myeloma treated with ide-cel for relapsed or refractory multiple myeloma at the Japanese Red Cross Medical Center (JRCMC; Tokyo, Japan) were analyzed.The institutional review board of JRCMC approved this study (approval number: 1738).Informed consent was obtained from all participants under the opt-out consent principle.No participants were excluded, and the study was conducted in accordance with the Declaration of Helsinki.CMV seropositivity was defined as a CMV IgG level of ≥6.0 AU/mL, as measured via chemiluminescent immunoassay before ide-cel administration.CMV reactivation was defined as the presence of CMV antigenemia or CMV DNA in peripheral blood, with CMV DNA detected in plasma using a commercial real-time polymerase chain reaction (PCR) assay (detection limit: 35 IU/mL).Although weekly CMV PCR testing was preferred following ide-cel administration, the testing frequency was at the discretion of the attending physician.Fisher exact test was utilized for intergroup comparisons of categorical variables, whereas Student t test or the Mann-Whitney U test was employed for continuous variables.The probability of CMV reactivation was estimated utilizing cumulative incidence curves to account for relapses or deaths without CMV reactivation as competing events.Statistical significance was set at P < .05.All statistical analyses were performed utilizing EZR software (https://www. jichi.ac.jp/saitama-sct/SaitamaHP.files/statmedEN.html).11 Between October 2022 and April 2025, a total of 67 patients received ide-cel therapy.Among them, 44 were seropositive and 8 were seronegative for CMV, whereas CMV serostatus was unknown in 15 patients.No cases of CMV reactivation were observed among the CMV-seronegative patients.

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