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Изатуксимаб, помалидомид и дексаметазон в терапии рецидивирующей/рефрактерной множественной миеломы в реальной клинической практике
Изатуксимаб, помалидомид и дексаметазон в терапии рецидивирующей/рефрактерной множественной миеломы в реальной клинической практике
Птушкин В.В., Кочкарева Ю.Б., Сухова Е.А., Никитин Е.А. Изатуксимаб, помалидомид и дексаметазон в терапии рецидивирующей/рефрактерной множественной миеломы в реальной клинической практике. Терапевтический архив. 2024;96(12):1182–1189. DOI: 10.26442/00403660.2024.12.203075
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
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Аннотация
Цель. Оценить эффективность и переносимость комбинации изатуксимаба, помалидомида, дексаметазона (IsaPd) в терапии рецидивирующей рефрактерной множественной миеломы (РРММ) в условиях реальной клинической практики.
Материалы и методы. В ретроспективное исследование включены 60 больных (28 мужчин и 32 женщины в возрасте от 39 до 81 года, медиана возраста – 64 года) с рефрактерными и рецидивирующими формами ММ. Все пациенты получали изатуксимаб внутривенно в дозе 10 мг/кг (еженедельно в течение 1 цикла и 1 раз в 2 нед в последующие циклы), помалидомид 4 мг перорально 1 раз в сутки с 1 по 21-й день курса и дексаметазон еженедельно в дозе 40 мг (если возраст <75 лет) или 20 мг (если возраст ≥75 лет). Курсы IsaPd 28 дней назначали до прогрессирования РРММ или развития неприемлемой токсичности.
Результаты. Медиана наблюдения составила 17,3 мес (диапазон: 2–34 мес), медиана продолжительности ответа – 16,3 мес (диапазон: 2–27 мес). Частота общего ответа составила 65,0%. Полный ответ достигнут у 5 (8,3%) больных, очень хороший частичный ответ – у 18 (30%), частичный ответ – у 16 (26,7%), минимальный ответ – у 5 (8,3%), стабилизация – у 3 (5%), прогрессия – у 11 (18,3%). Медиана выживаемости без прогрессирования составила 16,1 мес (95% доверительный интервал 9,0–23,2), 12-месячная выживаемость без прогрессирования – 58,0%. Медиана общей выживаемости не достигнута, 12-месячная общая выживаемость составила 72,9%. Наиболее частыми нежелательными явлениями при применении данной схемы были инфекции верхних дыхательных путей (32%) и нейтропения (35%).
Заключение. Комбинация IsaPd демонстрирует благоприятный профиль токсичности и высокую эффективность у пациентов с РРММ в условиях реальной клинической практики.
Ключевые слова: множественная миелома, общая выживаемость, выживаемость без прогрессирования, изатуксимаб, помалидомид
Materials and methods. The retrospective study included 60 patients (28 men and 32 women aged 39 to 81 years, median age 64 years) with refractory and relapsed forms of MM. All patients received isatuximab intravenously at a dose of 10 mg/kg (weekly during cycle 1 and once every 2 weeks in subsequent cycles), pomalidomide 4 mg orally once a day from day 1 to day 21 of the course, and dexamethasone weekly at a dose of 40 mg (if age <75 years) or 20 mg (if age ≥75 years). IsaPd courses of 28 days were administered until RRMM progression or unacceptable toxicity.
Results. The median follow-up was 17.3 months (range 2–34 months) and the median duration of response was 16.3 months (range 2–27 months). The overall response rate was 65.0%. Complete response was achieved in 5 patients (8.3%), very good partial response in 18 (30%), partial response in 16 (26.7%), minimal response in 5 (8.3%), stabilization in 3 (5%), and progression in 11 (18.3%). Median progression-free survival was 16.1 months (95% confidence interval 9.0–23.2 months), 12-month progression-free survival was 58.0%. Median overall survival was not reached, 12-month overall survival was 72.9%. The most common adverse events with this regimen were upper respiratory tract infections (32%) and neutropenia (35%).
Conclusion. The IsaPd combination demonstrates a favorable toxicity profile and high efficacy in patients with RRMM in the real clinical practice setting.
Keywords: multiple myeloma, overall survival, progression-free survival, isatuximab, pomalidomide
Материалы и методы. В ретроспективное исследование включены 60 больных (28 мужчин и 32 женщины в возрасте от 39 до 81 года, медиана возраста – 64 года) с рефрактерными и рецидивирующими формами ММ. Все пациенты получали изатуксимаб внутривенно в дозе 10 мг/кг (еженедельно в течение 1 цикла и 1 раз в 2 нед в последующие циклы), помалидомид 4 мг перорально 1 раз в сутки с 1 по 21-й день курса и дексаметазон еженедельно в дозе 40 мг (если возраст <75 лет) или 20 мг (если возраст ≥75 лет). Курсы IsaPd 28 дней назначали до прогрессирования РРММ или развития неприемлемой токсичности.
Результаты. Медиана наблюдения составила 17,3 мес (диапазон: 2–34 мес), медиана продолжительности ответа – 16,3 мес (диапазон: 2–27 мес). Частота общего ответа составила 65,0%. Полный ответ достигнут у 5 (8,3%) больных, очень хороший частичный ответ – у 18 (30%), частичный ответ – у 16 (26,7%), минимальный ответ – у 5 (8,3%), стабилизация – у 3 (5%), прогрессия – у 11 (18,3%). Медиана выживаемости без прогрессирования составила 16,1 мес (95% доверительный интервал 9,0–23,2), 12-месячная выживаемость без прогрессирования – 58,0%. Медиана общей выживаемости не достигнута, 12-месячная общая выживаемость составила 72,9%. Наиболее частыми нежелательными явлениями при применении данной схемы были инфекции верхних дыхательных путей (32%) и нейтропения (35%).
Заключение. Комбинация IsaPd демонстрирует благоприятный профиль токсичности и высокую эффективность у пациентов с РРММ в условиях реальной клинической практики.
Ключевые слова: множественная миелома, общая выживаемость, выживаемость без прогрессирования, изатуксимаб, помалидомид
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Materials and methods. The retrospective study included 60 patients (28 men and 32 women aged 39 to 81 years, median age 64 years) with refractory and relapsed forms of MM. All patients received isatuximab intravenously at a dose of 10 mg/kg (weekly during cycle 1 and once every 2 weeks in subsequent cycles), pomalidomide 4 mg orally once a day from day 1 to day 21 of the course, and dexamethasone weekly at a dose of 40 mg (if age <75 years) or 20 mg (if age ≥75 years). IsaPd courses of 28 days were administered until RRMM progression or unacceptable toxicity.
Results. The median follow-up was 17.3 months (range 2–34 months) and the median duration of response was 16.3 months (range 2–27 months). The overall response rate was 65.0%. Complete response was achieved in 5 patients (8.3%), very good partial response in 18 (30%), partial response in 16 (26.7%), minimal response in 5 (8.3%), stabilization in 3 (5%), and progression in 11 (18.3%). Median progression-free survival was 16.1 months (95% confidence interval 9.0–23.2 months), 12-month progression-free survival was 58.0%. Median overall survival was not reached, 12-month overall survival was 72.9%. The most common adverse events with this regimen were upper respiratory tract infections (32%) and neutropenia (35%).
Conclusion. The IsaPd combination demonstrates a favorable toxicity profile and high efficacy in patients with RRMM in the real clinical practice setting.
Keywords: multiple myeloma, overall survival, progression-free survival, isatuximab, pomalidomide
Полный текст
Список литературы
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3. Pinto V, Bergantim R, Caires HR, et al. Multiple myeloma: Available therapies and causes of drug resistance. Cancers (Basel). 2020;12(2):407. DOI:10.3390/cancers12020407
4. Bhatt P, Kloock C, Comenzo R. Relapsed/refractory multiple myeloma: A review of available therapies and clinical scenarios encountered in myeloma relapse. Curr Oncol. 2023;30(2):2322-47. DOI:10.3390/curroncol30020179
5. Ziccheddu B, Biancon G, Bagnoli F, et al. Integrative analysis of the genomic and transcriptomic landscape of double-refractory multiple myeloma. Blood Adv. 2020;4(5):830-44. DOI:10.1182/bloodadvances.2019000779
6. Allegra A, Tonacci A, Musolino C, et al. Secondary immunodeficiency in hematological malignancies: Focus on multiple myeloma and chronic lymphocytic leukemia. Front Immunol. 2021;12:738915. DOI:10.3389/fimmu.2021.738915
7. van de Donk NWCJ, Zweegman S. Monoclonal antibodies in the treatment of multiple myeloma. Hematol Oncol Clin North Am. 2024;38(2):337-60. DOI:10.1016/j.hoc.2023.12.002
8. Leleu X, Martin T, Weisel K, et al. Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: Differential mechanisms of action and recent clinical trial outcomes. Ann Hematol. 2022;101(10):2123-37. DOI:10.1007/s00277-022-04917-5
9. Petrucci MT, Vozella F. The anti-CD38 antibody therapy in multiple myeloma. Cells. 2019;8(12):1629-38. DOI:10.3390/cells8121629
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11. Attal M, Richardson PG, Rajkumar SV, et al. ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-107. DOI:10.1016/S0140-6736(19)32556-5. Erratum in: Lancet. 2019;394(10214):2072.
12. Hulin C, Richardson PG, Attal M, et al. Depth of response and response kinetics in the ICARIA-MM study of isatuximab with pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019;134(Suppl. 1):3185. DOI:10.1182/blood-2019-129840
13. Harrison SJ, Perrot A, Alegre A, et al. Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. Br J Haematol. 2021;194(1):120-31. DOI:10.1111/bjh.17499
14. Dimopoulos MA, Leleu X, Moreau P, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021;35(2):562-72. DOI:10.1038/s41375-020-0868-z
15. Richardson PG, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022;23(3):416-27. DOI:10.1016/S1470-2045(22)00019-5
16. Chari A, Romanus D, Palumbo A, et al. Randomized clinical trial representativeness and outcomes in real-world patients: Comparison of 6 hallmark randomized clinical trials of relapsed/refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2020;20(1):8-17.e16. DOI:10.1016/j.clml.2019.09.625
17. Bertamini L, Bertuglia G, Oliva S. Beyond clinical trials in patients with multiple myeloma: A critical review of real-world results. Front Oncol. 2022;12:844779. DOI:10.3389/fonc.2022.844779
18. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: A multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014;15(11):1195-206. DOI:10.1016/S1470-2045(14)70440-1. Erratum in: Lancet Oncol. 2015;16(1):e6.
19. Bird S, Pawlyn C, Nallamilli S, et al. A real-world study of panobinostat, weekly bortezomib and dexamethasone in a very heavily pretreated population of multiple-myeloma patients. Br J Haematol. 2020;191(5):927-30. DOI:10.1111/bjh.17076
20. Davies F, Rifkin R, Costello C, et al. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US. Ann Hematol. 2021;100(9):2325-37. DOI:10.1007/s00277-021-04534-8
21. Djebbari F, Rampotas A, Vallance G, et al. Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: Results of a UK-wide real-world dataset. Hemasphere. 2022;6(6):e738. DOI:10.1097/HS9.0000000000000738
22. Decaux O, Fontan J, Perrot A, et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study. Eur J Haematol. 2024;113(3):290-7. DOI:10.1111/ejh.14225
23. Tagami N, Uchiyama M, Suzuki K, et al. Isatuximab with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: Post-marketing surveillance in Japan. Int J Hematol. 2024;120(2):217-28. DOI:10.1007/s12185-024-03800-5
24. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-48. DOI:10.1016/S1470-2045(14)70442-5
25. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-46. DOI:10.1016/S1470-2045(16)30206-6
26. Rajkumar SV, Harousseau JL, Durie B, et al. International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: Report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011;117(18):4691-5. DOI:10.1182/blood-2010-10-299487
27. Richardson PG, Perrot A, Miguel JS, et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica. 2024;109(7):2239-49. DOI:10.3324/haematol.2023.284325
28. Capra MEZ, Beksac M, Richardson P, et al. Isatuximab plus pomalidomide and dexa-methasone in patients with relapsed/refractory multiple myeloma and soft-tissue plasmacytomas: ICARIA-MM subgroup analysis. Hematol Transfus Cell Ther. 2020;42:263-4. DOI:10.1016/j.htct.2020.10.440
29. Beksac M, Spicka I, Hajek R, et al. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022;122:106948. DOI:10.1016/j.leukres.2022.106948
2. Kumar S, Williamson M, Ogbu U, et al. Front-line treatment patterns in multiple myeloma: An analysis of U.S.-based electronic health records from 2011 to 2019. Cancer Med. 2021;10(17):5866-77. DOI:10.1002/cam4.4137
3. Pinto V, Bergantim R, Caires HR, et al. Multiple myeloma: Available therapies and causes of drug resistance. Cancers (Basel). 2020;12(2):407. DOI:10.3390/cancers12020407
4. Bhatt P, Kloock C, Comenzo R. Relapsed/refractory multiple myeloma: A review of available therapies and clinical scenarios encountered in myeloma relapse. Curr Oncol. 2023;30(2):2322-47. DOI:10.3390/curroncol30020179
5. Ziccheddu B, Biancon G, Bagnoli F, et al. Integrative analysis of the genomic and transcriptomic landscape of double-refractory multiple myeloma. Blood Adv. 2020;4(5):830-44. DOI:10.1182/bloodadvances.2019000779
6. Allegra A, Tonacci A, Musolino C, et al. Secondary immunodeficiency in hematological malignancies: Focus on multiple myeloma and chronic lymphocytic leukemia. Front Immunol. 2021;12:738915. DOI:10.3389/fimmu.2021.738915
7. van de Donk NWCJ, Zweegman S. Monoclonal antibodies in the treatment of multiple myeloma. Hematol Oncol Clin North Am. 2024;38(2):337-60. DOI:10.1016/j.hoc.2023.12.002
8. Leleu X, Martin T, Weisel K, et al. Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: Differential mechanisms of action and recent clinical trial outcomes. Ann Hematol. 2022;101(10):2123-37. DOI:10.1007/s00277-022-04917-5
9. Petrucci MT, Vozella F. The anti-CD38 antibody therapy in multiple myeloma. Cells. 2019;8(12):1629-38. DOI:10.3390/cells8121629
10. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018;379(19):1811-22. DOI:10.1056/NEJMoa1805762
11. Attal M, Richardson PG, Rajkumar SV, et al. ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-107. DOI:10.1016/S0140-6736(19)32556-5. Erratum in: Lancet. 2019;394(10214):2072.
12. Hulin C, Richardson PG, Attal M, et al. Depth of response and response kinetics in the ICARIA-MM study of isatuximab with pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019;134(Suppl. 1):3185. DOI:10.1182/blood-2019-129840
13. Harrison SJ, Perrot A, Alegre A, et al. Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. Br J Haematol. 2021;194(1):120-31. DOI:10.1111/bjh.17499
14. Dimopoulos MA, Leleu X, Moreau P, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021;35(2):562-72. DOI:10.1038/s41375-020-0868-z
15. Richardson PG, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022;23(3):416-27. DOI:10.1016/S1470-2045(22)00019-5
16. Chari A, Romanus D, Palumbo A, et al. Randomized clinical trial representativeness and outcomes in real-world patients: Comparison of 6 hallmark randomized clinical trials of relapsed/refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2020;20(1):8-17.e16. DOI:10.1016/j.clml.2019.09.625
17. Bertamini L, Bertuglia G, Oliva S. Beyond clinical trials in patients with multiple myeloma: A critical review of real-world results. Front Oncol. 2022;12:844779. DOI:10.3389/fonc.2022.844779
18. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: A multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014;15(11):1195-206. DOI:10.1016/S1470-2045(14)70440-1. Erratum in: Lancet Oncol. 2015;16(1):e6.
19. Bird S, Pawlyn C, Nallamilli S, et al. A real-world study of panobinostat, weekly bortezomib and dexamethasone in a very heavily pretreated population of multiple-myeloma patients. Br J Haematol. 2020;191(5):927-30. DOI:10.1111/bjh.17076
20. Davies F, Rifkin R, Costello C, et al. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US. Ann Hematol. 2021;100(9):2325-37. DOI:10.1007/s00277-021-04534-8
21. Djebbari F, Rampotas A, Vallance G, et al. Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: Results of a UK-wide real-world dataset. Hemasphere. 2022;6(6):e738. DOI:10.1097/HS9.0000000000000738
22. Decaux O, Fontan J, Perrot A, et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study. Eur J Haematol. 2024;113(3):290-7. DOI:10.1111/ejh.14225
23. Tagami N, Uchiyama M, Suzuki K, et al. Isatuximab with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: Post-marketing surveillance in Japan. Int J Hematol. 2024;120(2):217-28. DOI:10.1007/s12185-024-03800-5
24. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-48. DOI:10.1016/S1470-2045(14)70442-5
25. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-46. DOI:10.1016/S1470-2045(16)30206-6
26. Rajkumar SV, Harousseau JL, Durie B, et al. International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: Report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011;117(18):4691-5. DOI:10.1182/blood-2010-10-299487
27. Richardson PG, Perrot A, Miguel JS, et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica. 2024;109(7):2239-49. DOI:10.3324/haematol.2023.284325
28. Capra MEZ, Beksac M, Richardson P, et al. Isatuximab plus pomalidomide and dexa-methasone in patients with relapsed/refractory multiple myeloma and soft-tissue plasmacytomas: ICARIA-MM subgroup analysis. Hematol Transfus Cell Ther. 2020;42:263-4. DOI:10.1016/j.htct.2020.10.440
29. Beksac M, Spicka I, Hajek R, et al. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022;122:106948. DOI:10.1016/j.leukres.2022.106948
2. Kumar S, Williamson M, Ogbu U, et al. Front-line treatment patterns in multiple myeloma: An analysis of U.S.-based electronic health records from 2011 to 2019. Cancer Med. 2021;10(17):5866-77. DOI:10.1002/cam4.4137
3. Pinto V, Bergantim R, Caires HR, et al. Multiple myeloma: Available therapies and causes of drug resistance. Cancers (Basel). 2020;12(2):407. DOI:10.3390/cancers12020407
4. Bhatt P, Kloock C, Comenzo R. Relapsed/refractory multiple myeloma: A review of available therapies and clinical scenarios encountered in myeloma relapse. Curr Oncol. 2023;30(2):2322-47. DOI:10.3390/curroncol30020179
5. Ziccheddu B, Biancon G, Bagnoli F, et al. Integrative analysis of the genomic and transcriptomic landscape of double-refractory multiple myeloma. Blood Adv. 2020;4(5):830-44. DOI:10.1182/bloodadvances.2019000779
6. Allegra A, Tonacci A, Musolino C, et al. Secondary immunodeficiency in hematological malignancies: Focus on multiple myeloma and chronic lymphocytic leukemia. Front Immunol. 2021;12:738915. DOI:10.3389/fimmu.2021.738915
7. van de Donk NWCJ, Zweegman S. Monoclonal antibodies in the treatment of multiple myeloma. Hematol Oncol Clin North Am. 2024;38(2):337-60. DOI:10.1016/j.hoc.2023.12.002
8. Leleu X, Martin T, Weisel K, et al. Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: Differential mechanisms of action and recent clinical trial outcomes. Ann Hematol. 2022;101(10):2123-37. DOI:10.1007/s00277-022-04917-5
9. Petrucci MT, Vozella F. The anti-CD38 antibody therapy in multiple myeloma. Cells. 2019;8(12):1629-38. DOI:10.3390/cells8121629
10. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018;379(19):1811-22. DOI:10.1056/NEJMoa1805762
11. Attal M, Richardson PG, Rajkumar SV, et al. ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-107. DOI:10.1016/S0140-6736(19)32556-5. Erratum in: Lancet. 2019;394(10214):2072.
12. Hulin C, Richardson PG, Attal M, et al. Depth of response and response kinetics in the ICARIA-MM study of isatuximab with pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019;134(Suppl. 1):3185. DOI:10.1182/blood-2019-129840
13. Harrison SJ, Perrot A, Alegre A, et al. Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. Br J Haematol. 2021;194(1):120-31. DOI:10.1111/bjh.17499
14. Dimopoulos MA, Leleu X, Moreau P, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021;35(2):562-72. DOI:10.1038/s41375-020-0868-z
15. Richardson PG, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022;23(3):416-27. DOI:10.1016/S1470-2045(22)00019-5
16. Chari A, Romanus D, Palumbo A, et al. Randomized clinical trial representativeness and outcomes in real-world patients: Comparison of 6 hallmark randomized clinical trials of relapsed/refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2020;20(1):8-17.e16. DOI:10.1016/j.clml.2019.09.625
17. Bertamini L, Bertuglia G, Oliva S. Beyond clinical trials in patients with multiple myeloma: A critical review of real-world results. Front Oncol. 2022;12:844779. DOI:10.3389/fonc.2022.844779
18. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: A multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014;15(11):1195-206. DOI:10.1016/S1470-2045(14)70440-1. Erratum in: Lancet Oncol. 2015;16(1):e6.
19. Bird S, Pawlyn C, Nallamilli S, et al. A real-world study of panobinostat, weekly bortezomib and dexamethasone in a very heavily pretreated population of multiple-myeloma patients. Br J Haematol. 2020;191(5):927-30. DOI:10.1111/bjh.17076
20. Davies F, Rifkin R, Costello C, et al. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US. Ann Hematol. 2021;100(9):2325-37. DOI:10.1007/s00277-021-04534-8
21. Djebbari F, Rampotas A, Vallance G, et al. Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: Results of a UK-wide real-world dataset. Hemasphere. 2022;6(6):e738. DOI:10.1097/HS9.0000000000000738
22. Decaux O, Fontan J, Perrot A, et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study. Eur J Haematol. 2024;113(3):290-7. DOI:10.1111/ejh.14225
23. Tagami N, Uchiyama M, Suzuki K, et al. Isatuximab with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: Post-marketing surveillance in Japan. Int J Hematol. 2024;120(2):217-28. DOI:10.1007/s12185-024-03800-5
24. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-48. DOI:10.1016/S1470-2045(14)70442-5
25. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-46. DOI:10.1016/S1470-2045(16)30206-6
26. Rajkumar SV, Harousseau JL, Durie B, et al. International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: Report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011;117(18):4691-5. DOI:10.1182/blood-2010-10-299487
27. Richardson PG, Perrot A, Miguel JS, et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica. 2024;109(7):2239-49. DOI:10.3324/haematol.2023.284325
28. Capra MEZ, Beksac M, Richardson P, et al. Isatuximab plus pomalidomide and dexa-methasone in patients with relapsed/refractory multiple myeloma and soft-tissue plasmacytomas: ICARIA-MM subgroup analysis. Hematol Transfus Cell Ther. 2020;42:263-4. DOI:10.1016/j.htct.2020.10.440
29. Beksac M, Spicka I, Hajek R, et al. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022;122:106948. DOI:10.1016/j.leukres.2022.106948
________________________________________________
2. Kumar S, Williamson M, Ogbu U, et al. Front-line treatment patterns in multiple myeloma: An analysis of U.S.-based electronic health records from 2011 to 2019. Cancer Med. 2021;10(17):5866-77. DOI:10.1002/cam4.4137
3. Pinto V, Bergantim R, Caires HR, et al. Multiple myeloma: Available therapies and causes of drug resistance. Cancers (Basel). 2020;12(2):407. DOI:10.3390/cancers12020407
4. Bhatt P, Kloock C, Comenzo R. Relapsed/refractory multiple myeloma: A review of available therapies and clinical scenarios encountered in myeloma relapse. Curr Oncol. 2023;30(2):2322-47. DOI:10.3390/curroncol30020179
5. Ziccheddu B, Biancon G, Bagnoli F, et al. Integrative analysis of the genomic and transcriptomic landscape of double-refractory multiple myeloma. Blood Adv. 2020;4(5):830-44. DOI:10.1182/bloodadvances.2019000779
6. Allegra A, Tonacci A, Musolino C, et al. Secondary immunodeficiency in hematological malignancies: Focus on multiple myeloma and chronic lymphocytic leukemia. Front Immunol. 2021;12:738915. DOI:10.3389/fimmu.2021.738915
7. van de Donk NWCJ, Zweegman S. Monoclonal antibodies in the treatment of multiple myeloma. Hematol Oncol Clin North Am. 2024;38(2):337-60. DOI:10.1016/j.hoc.2023.12.002
8. Leleu X, Martin T, Weisel K, et al. Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: Differential mechanisms of action and recent clinical trial outcomes. Ann Hematol. 2022;101(10):2123-37. DOI:10.1007/s00277-022-04917-5
9. Petrucci MT, Vozella F. The anti-CD38 antibody therapy in multiple myeloma. Cells. 2019;8(12):1629-38. DOI:10.3390/cells8121629
10. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018;379(19):1811-22. DOI:10.1056/NEJMoa1805762
11. Attal M, Richardson PG, Rajkumar SV, et al. ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-107. DOI:10.1016/S0140-6736(19)32556-5. Erratum in: Lancet. 2019;394(10214):2072.
12. Hulin C, Richardson PG, Attal M, et al. Depth of response and response kinetics in the ICARIA-MM study of isatuximab with pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019;134(Suppl. 1):3185. DOI:10.1182/blood-2019-129840
13. Harrison SJ, Perrot A, Alegre A, et al. Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. Br J Haematol. 2021;194(1):120-31. DOI:10.1111/bjh.17499
14. Dimopoulos MA, Leleu X, Moreau P, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021;35(2):562-72. DOI:10.1038/s41375-020-0868-z
15. Richardson PG, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022;23(3):416-27. DOI:10.1016/S1470-2045(22)00019-5
16. Chari A, Romanus D, Palumbo A, et al. Randomized clinical trial representativeness and outcomes in real-world patients: Comparison of 6 hallmark randomized clinical trials of relapsed/refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2020;20(1):8-17.e16. DOI:10.1016/j.clml.2019.09.625
17. Bertamini L, Bertuglia G, Oliva S. Beyond clinical trials in patients with multiple myeloma: A critical review of real-world results. Front Oncol. 2022;12:844779. DOI:10.3389/fonc.2022.844779
18. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: A multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014;15(11):1195-206. DOI:10.1016/S1470-2045(14)70440-1. Erratum in: Lancet Oncol. 2015;16(1):e6.
19. Bird S, Pawlyn C, Nallamilli S, et al. A real-world study of panobinostat, weekly bortezomib and dexamethasone in a very heavily pretreated population of multiple-myeloma patients. Br J Haematol. 2020;191(5):927-30. DOI:10.1111/bjh.17076
20. Davies F, Rifkin R, Costello C, et al. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US. Ann Hematol. 2021;100(9):2325-37. DOI:10.1007/s00277-021-04534-8
21. Djebbari F, Rampotas A, Vallance G, et al. Efficacy of isatuximab with pomalidomide and dexamethasone in relapsed myeloma: Results of a UK-wide real-world dataset. Hemasphere. 2022;6(6):e738. DOI:10.1097/HS9.0000000000000738
22. Decaux O, Fontan J, Perrot A, et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study. Eur J Haematol. 2024;113(3):290-7. DOI:10.1111/ejh.14225
23. Tagami N, Uchiyama M, Suzuki K, et al. Isatuximab with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: Post-marketing surveillance in Japan. Int J Hematol. 2024;120(2):217-28. DOI:10.1007/s12185-024-03800-5
24. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-48. DOI:10.1016/S1470-2045(14)70442-5
25. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-46. DOI:10.1016/S1470-2045(16)30206-6
26. Rajkumar SV, Harousseau JL, Durie B, et al. International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: Report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011;117(18):4691-5. DOI:10.1182/blood-2010-10-299487
27. Richardson PG, Perrot A, Miguel JS, et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica. 2024;109(7):2239-49. DOI:10.3324/haematol.2023.284325
28. Capra MEZ, Beksac M, Richardson P, et al. Isatuximab plus pomalidomide and dexa-methasone in patients with relapsed/refractory multiple myeloma and soft-tissue plasmacytomas: ICARIA-MM subgroup analysis. Hematol Transfus Cell Ther. 2020;42:263-4. DOI:10.1016/j.htct.2020.10.440
29. Beksac M, Spicka I, Hajek R, et al. Evaluation of isatuximab in patients with soft-tissue plasmacytomas: An analysis from ICARIA-MM and IKEMA. Leuk Res. 2022;122:106948. DOI:10.1016/j.leukres.2022.106948
Авторы
В.В. Птушкин1–3, Ю.Б. Кочкарева*1, Е.А. Сухова1, Е.А. Никитин1,3
1ГБУЗ г. Москвы «Московский многопрофильный научно-клинический центр им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
2ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
3ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия
*kochkareva_yulia@mail.ru
1Botkin Moscow Multidisciplinary Research and Clinical Center, Moscow, Russia;
2Pirogov Russian National Research Medical University, Moscow, Russia;
3Russian Medical Academy of Continuous Professional Education, Moscow, Russia
*kochkareva_yulia@mail.ru
1ГБУЗ г. Москвы «Московский многопрофильный научно-клинический центр им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
2ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
3ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия
*kochkareva_yulia@mail.ru
________________________________________________
1Botkin Moscow Multidisciplinary Research and Clinical Center, Moscow, Russia;
2Pirogov Russian National Research Medical University, Moscow, Russia;
3Russian Medical Academy of Continuous Professional Education, Moscow, Russia
*kochkareva_yulia@mail.ru
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