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Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma
Idecabtagene vicleucel (ide-cel) was FDA-approved in March 2021 for the treatment of relapsed/refractory multiple myeloma after 4 lines of therapy. On the KarMMa trial, grade ≥ 3 cytopenias and infections were common. We sought to characterize cytopenias and infections within 100 days after ide-cel...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The American Society of Hematology
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9768247/ https://www.ncbi.nlm.nih.gov/pubmed/35939783 http://dx.doi.org/10.1182/bloodadvances.2022008320 |
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author | Logue, Jennifer M. Peres, Lauren C. Hashmi, Hamza Colin-Leitzinger, Christelle M. Shrewsbury, Alexandria M. Hosoya, Hitomi Gonzalez, Rebecca M. Copponex, Christina Kottra, Krista H. Hovanky, Vanna Sahaf, Bita Patil, Sunita Lazaryan, Aleksandr Jain, Michael D. Baluch, Aliyah Klinkova, Olga V. Bejanyan, Nelli Faramand, Rawan G. Elmariah, Hany Khimani, Farhad Davila, Marco L. Mishra, Asmita Blue, Brandon J. Grajales-Cruz, Ariel F. Castaneda Puglianini, Omar A. Liu, Hien D. Nishihori, Taiga Freeman, Ciara L. Brayer, Jason B. Shain, Kenneth H. Baz, Rachid C. Locke, Frederick L. Alsina, Melissa Sidana, Surbhi Hansen, Doris K. |
author_facet | Logue, Jennifer M. Peres, Lauren C. Hashmi, Hamza Colin-Leitzinger, Christelle M. Shrewsbury, Alexandria M. Hosoya, Hitomi Gonzalez, Rebecca M. Copponex, Christina Kottra, Krista H. Hovanky, Vanna Sahaf, Bita Patil, Sunita Lazaryan, Aleksandr Jain, Michael D. Baluch, Aliyah Klinkova, Olga V. Bejanyan, Nelli Faramand, Rawan G. Elmariah, Hany Khimani, Farhad Davila, Marco L. Mishra, Asmita Blue, Brandon J. Grajales-Cruz, Ariel F. Castaneda Puglianini, Omar A. Liu, Hien D. Nishihori, Taiga Freeman, Ciara L. Brayer, Jason B. Shain, Kenneth H. Baz, Rachid C. Locke, Frederick L. Alsina, Melissa Sidana, Surbhi Hansen, Doris K. |
author_sort | Logue, Jennifer M. |
collection | PubMed |
description | Idecabtagene vicleucel (ide-cel) was FDA-approved in March 2021 for the treatment of relapsed/refractory multiple myeloma after 4 lines of therapy. On the KarMMa trial, grade ≥ 3 cytopenias and infections were common. We sought to characterize cytopenias and infections within 100 days after ide-cel in the standard-of-care (SOC) setting. This multi-center retrospective study included 52 patients who received SOC ide-cel; 47 reached day-90 follow-up. Data were censored at day 100. Grade ≥ 3 cytopenia was present among 65% of patients at day 30 and 40% of patients at day 90. Granulocyte colony stimulating factor (G-CSF) was administered to 88%, packed red blood cell transfusions to 63%, platelet transfusions to 42%, thrombopoietin (TPO) agonists to 21%, intravenous immunoglobulin to 13%, and CD34(+) stem cell boosts to 8%. At day 100, 19% and 13% of patients had ongoing use of TPO agonists and G-CSF, respectively. Infections occurred in 54% of patients and were grade ≥ 3 in 23%. Earlier infections in the first 30 days were typically bacterial (68%) and severe (50%). Later infections between days 31 and 100 were 50% bacterial and 42% viral; only 13% were grade ≥ 3. On univariate analysis, high pre-CAR-T marrow myeloma burden (≥ 50%), circulating plasma cells at pre-lymphodepletion (LD), and grade ≥ 3 anemia at pre-LD were associated with grade ≥ 3 cytopenia at both days 30 and 90. Longer time from last bridging treatment to LD was the only significant risk factor for infection. |
format | Online Article Text |
id | pubmed-9768247 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The American Society of Hematology |
record_format | MEDLINE/PubMed |
spelling | pubmed-97682472022-12-28 Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma Logue, Jennifer M. Peres, Lauren C. Hashmi, Hamza Colin-Leitzinger, Christelle M. Shrewsbury, Alexandria M. Hosoya, Hitomi Gonzalez, Rebecca M. Copponex, Christina Kottra, Krista H. Hovanky, Vanna Sahaf, Bita Patil, Sunita Lazaryan, Aleksandr Jain, Michael D. Baluch, Aliyah Klinkova, Olga V. Bejanyan, Nelli Faramand, Rawan G. Elmariah, Hany Khimani, Farhad Davila, Marco L. Mishra, Asmita Blue, Brandon J. Grajales-Cruz, Ariel F. Castaneda Puglianini, Omar A. Liu, Hien D. Nishihori, Taiga Freeman, Ciara L. Brayer, Jason B. Shain, Kenneth H. Baz, Rachid C. Locke, Frederick L. Alsina, Melissa Sidana, Surbhi Hansen, Doris K. Blood Adv Regular Article Idecabtagene vicleucel (ide-cel) was FDA-approved in March 2021 for the treatment of relapsed/refractory multiple myeloma after 4 lines of therapy. On the KarMMa trial, grade ≥ 3 cytopenias and infections were common. We sought to characterize cytopenias and infections within 100 days after ide-cel in the standard-of-care (SOC) setting. This multi-center retrospective study included 52 patients who received SOC ide-cel; 47 reached day-90 follow-up. Data were censored at day 100. Grade ≥ 3 cytopenia was present among 65% of patients at day 30 and 40% of patients at day 90. Granulocyte colony stimulating factor (G-CSF) was administered to 88%, packed red blood cell transfusions to 63%, platelet transfusions to 42%, thrombopoietin (TPO) agonists to 21%, intravenous immunoglobulin to 13%, and CD34(+) stem cell boosts to 8%. At day 100, 19% and 13% of patients had ongoing use of TPO agonists and G-CSF, respectively. Infections occurred in 54% of patients and were grade ≥ 3 in 23%. Earlier infections in the first 30 days were typically bacterial (68%) and severe (50%). Later infections between days 31 and 100 were 50% bacterial and 42% viral; only 13% were grade ≥ 3. On univariate analysis, high pre-CAR-T marrow myeloma burden (≥ 50%), circulating plasma cells at pre-lymphodepletion (LD), and grade ≥ 3 anemia at pre-LD were associated with grade ≥ 3 cytopenia at both days 30 and 90. Longer time from last bridging treatment to LD was the only significant risk factor for infection. The American Society of Hematology 2022-08-10 /pmc/articles/PMC9768247/ /pubmed/35939783 http://dx.doi.org/10.1182/bloodadvances.2022008320 Text en © 2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Regular Article Logue, Jennifer M. Peres, Lauren C. Hashmi, Hamza Colin-Leitzinger, Christelle M. Shrewsbury, Alexandria M. Hosoya, Hitomi Gonzalez, Rebecca M. Copponex, Christina Kottra, Krista H. Hovanky, Vanna Sahaf, Bita Patil, Sunita Lazaryan, Aleksandr Jain, Michael D. Baluch, Aliyah Klinkova, Olga V. Bejanyan, Nelli Faramand, Rawan G. Elmariah, Hany Khimani, Farhad Davila, Marco L. Mishra, Asmita Blue, Brandon J. Grajales-Cruz, Ariel F. Castaneda Puglianini, Omar A. Liu, Hien D. Nishihori, Taiga Freeman, Ciara L. Brayer, Jason B. Shain, Kenneth H. Baz, Rachid C. Locke, Frederick L. Alsina, Melissa Sidana, Surbhi Hansen, Doris K. Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
title | Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
title_full | Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
title_fullStr | Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
title_full_unstemmed | Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
title_short | Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
title_sort | early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma |
topic | Regular Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9768247/ https://www.ncbi.nlm.nih.gov/pubmed/35939783 http://dx.doi.org/10.1182/bloodadvances.2022008320 |
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