Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience
<b>Background/Objectives:</b> Idecabtagene vicleucel (ide-cel), an anti-B-cell maturation chimeric antigen receptor T-cell therapy, represents an unprecedented treatment option for relapsed/refractory multiple myeloma (R/R MM). Nevertheless, given its limitations, including the risk of a...
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2024-12-01
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| author | Aaron Trando Farid Ghamsari Philip Yeung Caitlin Costello Ila Saunders Ah-Reum Jeong |
| author_facet | Aaron Trando Farid Ghamsari Philip Yeung Caitlin Costello Ila Saunders Ah-Reum Jeong |
| author_sort | Aaron Trando |
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| description | <b>Background/Objectives:</b> Idecabtagene vicleucel (ide-cel), an anti-B-cell maturation chimeric antigen receptor T-cell therapy, represents an unprecedented treatment option for relapsed/refractory multiple myeloma (R/R MM). Nevertheless, given its limitations, including the risk of adverse effects and unclear durability of efficacy, there remains a need to report the real-world clinical outcomes of ide-cel therapy in patients with R/R MM, as well as explore host predictive factors for therapy. <b>Methods:</b> We performed a single-center retrospective analysis of 25 adult patients with R/R MM who received ide-cel between 2021 and 2023 at the University of California San Diego Health. Data on baseline characteristics, efficacy, safety, and post-relapse outcomes were collected. Treatment responses were assessed using the International Myeloma Working Group criteria while survival analyses were conducted using the Kaplan–Meier and Cox proportional hazards methods. <b>Results:</b> The median age was 65. Twelve patients (48%) were male. Patients received a median of six lines of prior therapy with four patients (16%) receiving prior BCMA-targeted therapy. Six patients (24%) had high-risk cytogenetics while ten patients (40%) had extramedullary disease. The incidence of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome incidence was 92% and 12%, respectively. All grade infection occurred in 11 patients (44%). Cytomegalovirus (CMV) reactivation occurred in 9 of 19 patients (47%) who were CMV IgG positive prior to CAR T-cell therapy. The objective response rate (ORR) was 84%; stringent complete response was seen in 14 patients (56%). After a median follow-up of 13 months, median progression-free survival (PFS) was 13.9 months (95% CI: 9.21 months—not reached [NR]); median overall survival (OS) was not reached (95% CI: 19.5 months—NR). Among the 11 patients (44%) who progressed after ide-cel therapy, median OS2 was 13.7 months; especially poor outcomes (median OS2 of 1.74 months) were observed in four patients who did not respond to ide-cel. Six of these eleven patients remained alive at time of data cutoff. Univariate and multivariate analysis revealed no significant predictors of ORR, PFS, or OS. <b>Conclusions:</b> Overall, ide-cel had comparable efficacy and safety to the KarMMa-1 trial and other reported real-world experiences. |
| format | Article |
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| institution | Kabale University |
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| spelling | doaj-art-0d6b857eef3a45759ea08625ce113ce22025-01-24T13:23:47ZengMDPI AGBiomedicines2227-90592024-12-011313610.3390/biomedicines13010036Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution ExperienceAaron Trando0Farid Ghamsari1Philip Yeung2Caitlin Costello3Ila Saunders4Ah-Reum Jeong5School of Medicine, University of California San Diego, La Jolla, CA 92093, USADepartment of Internal Medicine, University of California San Diego, La Jolla, CA 92093, USAMaster of Advanced Studies (MAS) Program in Clinical Research, University of California San Diego, La Jolla, CA 92093, USADepartment of Medicine, Division of Blood and Marrow Transplantation, University of California San Diego, La Jolla, CA 92093, USASkaggs School of Pharmacy & Pharmaceutical Sciences, University of California San Diego, La Jolla, CA 92093, USADepartment of Medicine, Division of Blood and Marrow Transplantation, University of California San Diego, La Jolla, CA 92093, USA<b>Background/Objectives:</b> Idecabtagene vicleucel (ide-cel), an anti-B-cell maturation chimeric antigen receptor T-cell therapy, represents an unprecedented treatment option for relapsed/refractory multiple myeloma (R/R MM). Nevertheless, given its limitations, including the risk of adverse effects and unclear durability of efficacy, there remains a need to report the real-world clinical outcomes of ide-cel therapy in patients with R/R MM, as well as explore host predictive factors for therapy. <b>Methods:</b> We performed a single-center retrospective analysis of 25 adult patients with R/R MM who received ide-cel between 2021 and 2023 at the University of California San Diego Health. Data on baseline characteristics, efficacy, safety, and post-relapse outcomes were collected. Treatment responses were assessed using the International Myeloma Working Group criteria while survival analyses were conducted using the Kaplan–Meier and Cox proportional hazards methods. <b>Results:</b> The median age was 65. Twelve patients (48%) were male. Patients received a median of six lines of prior therapy with four patients (16%) receiving prior BCMA-targeted therapy. Six patients (24%) had high-risk cytogenetics while ten patients (40%) had extramedullary disease. The incidence of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome incidence was 92% and 12%, respectively. All grade infection occurred in 11 patients (44%). Cytomegalovirus (CMV) reactivation occurred in 9 of 19 patients (47%) who were CMV IgG positive prior to CAR T-cell therapy. The objective response rate (ORR) was 84%; stringent complete response was seen in 14 patients (56%). After a median follow-up of 13 months, median progression-free survival (PFS) was 13.9 months (95% CI: 9.21 months—not reached [NR]); median overall survival (OS) was not reached (95% CI: 19.5 months—NR). Among the 11 patients (44%) who progressed after ide-cel therapy, median OS2 was 13.7 months; especially poor outcomes (median OS2 of 1.74 months) were observed in four patients who did not respond to ide-cel. Six of these eleven patients remained alive at time of data cutoff. Univariate and multivariate analysis revealed no significant predictors of ORR, PFS, or OS. <b>Conclusions:</b> Overall, ide-cel had comparable efficacy and safety to the KarMMa-1 trial and other reported real-world experiences.https://www.mdpi.com/2227-9059/13/1/36CAR T-cell therapyide-celmultiple myelomaCRSICANScytomegalovirus |
| spellingShingle | Aaron Trando Farid Ghamsari Philip Yeung Caitlin Costello Ila Saunders Ah-Reum Jeong Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience Biomedicines CAR T-cell therapy ide-cel multiple myeloma CRS ICANS cytomegalovirus |
| title | Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience |
| title_full | Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience |
| title_fullStr | Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience |
| title_full_unstemmed | Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience |
| title_short | Outcomes of Idecabtagene Vicleucel Therapy in Patients with Relapsed/Refractory Multiple Myeloma: A Single-Institution Experience |
| title_sort | outcomes of idecabtagene vicleucel therapy in patients with relapsed refractory multiple myeloma a single institution experience |
| topic | CAR T-cell therapy ide-cel multiple myeloma CRS ICANS cytomegalovirus |
| url | https://www.mdpi.com/2227-9059/13/1/36 |
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