Множественной миеломы: диагностика и терапия (часть 2)

Множественной миеломы: диагностика и терапия (часть 2)

Автор: Бессмельцев С.С.

Журнал: Вестник гематологии @bulletin-of-hematology

Рубрика: Передовая статья

Статья в выпуске: 3 т.18, 2022 года.

Бесплатный доступ

Использование новых подходов в лечении рецидивов и рефрактерных форм множественной миеломы (ММ) привело к существенному улучшению общей выживаемости больных и выживаемости без прогрессирования, достижению качественного и длительного ответа. Эти изменения связаны главным образом с применением новых препаратов: ингибиторов претеасом, иммуномодулирующих препаратов, моноклональных антител, каждый из которых обладает выраженной противоопухолевой активностью. В настоящее время число препаратов, которые используются при ММ, достаточно большое, причем спектр их все более расширяется. Тем не менее результаты лечения больных с рецидивами/рефрактерными формами ММ не вполне удовлетворительные, что свидетельствует о трудностях разработки эффективных лекарственных средств. Появилось большое количество препаратов второго и третьего поколениия, моноклональных антител, которые становятся все более доступными для клинического применения. Уже получены убедительные данные по высокой эффективности биспецифических антител. Привлекает внимание новая медицинский технология - CAR-T терапия. В обзоре представлены современные подходы к ведению пациентов с рецидивами и рефрактерным течением ММ, основанные на результатах клинических исследовании, целью которых было оптимизировать результаты лечения. Представлена эффективность различных классов новых лекарственных средств, обсуждены все «за» и «против», полученные в клинических исследованиях. Подробно освещены побочные эффекты новых препаратов.

Еще

Множественная миелома, рецидив, рефрактерное течение, бортезомиб, леналидомид, карфилзомиб, помалидомид, моноклональные антитела, биспецифические антитела, car-t терапия, выживаемость

Короткий адрес: https://sciup.org/170195752

ID: 170195752

Список литературы Множественной миеломы: диагностика и терапия (часть 2)

  • Бессмельцев С.С. Множественная миелома: диагностика и терапия (Часть1)//Вестник гематологии. - 2022. - Т. XVIII, №2. - С. 4-26.
  • Fonseca R., Usmani S.Z., Mehra M. et al. Frontline treatment patterns and attrition rates by subsequent lines of therapy in patients with newly diagnosed multiple myeloma. - BMC Cancer. - 2020. - Vol. 20. - P. 1087-1098.
  • Бессмельцев С.С., Абдулкадыров К.М. Множественная миелома: рук. для врачей. - М.: МК, 2016. - 504 с.
  • Dimopoulos M-A., Richardson P., Lonial S. Treatment options for patients with heavily pretreated relapsed and refractory multiple myeloma// Clinical Lymphoma Myeloma and Leukemia. - Available online 10 January 2022. https://doi. org/10.1016/j.clml.2022.01.005Get rights and content.
  • Бессмельцев С.С., Карягина Е.В., Илюшкина Е.Ю., Столыпина Ж.Л., Мифтахова Р.Р., Кострома И.И., Шелковская Т.Л. Клиническая эффективность даратумумаба в монотерапии рецидивов и рефрактерных форм множественной ми-еломы//Клиническая онкогематология. - 2020. - Т. 23, №1. - С. 25-32.
  • Moreau P. How I treat myeloma with new agents. - Blood. - 2017. - Vol. 130. - P. 1507-1513.
  • Richardson P.G., San Miguel J.F., Moreau P. et al. Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting. //Blood Cancer J. - Vol. 2018. - Vol. 8. - P. 109.
  • Sonneveld P., Avet-Loiseau H, Lonial S. et al. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group.// Blood. - 2016. - Vol. 127, N 24. - P. 2955-2962.
  • Philippe Moreau, Shaji K Kumar, Jesús San Miguel et al. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group// Lancet Oncol. - 2021. - Vol. 22. - P. e10S-e118.
  • McCarthy P.L., Holstein S.A., Petrucci M.T. et al. Lenalidomide maintenance after autologous stem-cell transplantation in newly diagnosed multiple myeloma: a meta-analysis. // J Clin Oncol. - 2017. - Vol. 3S. - P. 3279-3289.
  • Jackson G.H., Davies F.E., Pawlyn C. et al. Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial// Lancet Oncol. - 2019. - Vol. 20. - P. S7-73.
  • Reece D.E., Masih-Khan E., Atenafu E.G. et al. Retrospective study of treatment patterns and outcomes post-lenalidomide for multiple myeloma in Canada.// Eur J Haematol. - 2021. - Vol. 107, N 4. - P. 416-427.
  • Nijhof I.S., Franssen L.E., Levin M.D. et al. Phase 1/2 study of lenalidomide combined with low-dose cyclophosphamide and prednisone in lenalidomide-refractory multiple myeloma.// Blood. - 2016. - Vol. 128. - P. 2297-22306.
  • Бессмельцев С.С., Стельмашенко Л.В., Карягина Е.В. и др. Лечение рефрактерных/рецидивирующих форм множественной миеломы// Биомедицинский журнал Medline.ru. - 2011. - Т. 12. - С. 763-780.
  • Бессмельцев С.С. Множественная миелома (лечение рецидивов и рефрактерных форм): обзор литературы и собственные данные. Часть III// Клиническая Онкогематология. - 2014. - №2. - С. 137-174.
  • Dimopoulos M.A., Moreau P., Palumbo A. et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study // Lancet Oncol. - 2016. - Vol. 17. - P. 27-38.
  • Dimopoulos M.A., Goldschmidt H., Niesvizky R. et al. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial// Lancet Oncol. - 2017. - Vol. 18. - P. 1327-1337.
  • Moreau P., Joshua D., Chang W.J. et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study// Leukemia. - 2017. - Vol. 31. - P. 11S-122.
  • Palumbo A., Chanan-Khan A., Weisel K. et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma.//N Engl J Med. - 2016. - Vol. 37S. - P. 7S4-766.
  • Weisel K.C., Sonneveld P., Mateos M-V. et al. Efficacy and safety of daratumumab, bortezomib, and dexamethasone (D-Vd) versus bortezomib and dexamethasone (Vd) in first relapse patients with multiple myeloma: four-year update of CASTOR// Blood. - 2019. - Vol. 134, Suppl 1. - P. 3192.
  • San-Miguel J.F., Hungria V.T., Yoon S.S. et al. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial.// Lancet Haematol. - 2016. - Vol. 3. - P. eS06-S1S.
  • Richardson P.G., Oriol A., Beksac M. et al. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial// Lancet Oncol. - 2019. - Vol. 20. - P. 781-794.
  • Dimopoulos M., Quach H., Mateos M.V. et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study// Lancet. - 2020. - Vol. 396. - P. 186-197.
  • Moreau P., Dimopoulos M., Mikhael J. et al. Isatuximab plus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma (IKEMA): interim analysis of a phase 3, randomized, open-label study// All-Virtual 62nd ASH Annual Meeting & Exposition; S-8 декабря 2020, Abstr. 2316.
  • Larocca A, Montefusco V, Bringhen S, et al. Pomalidomide, cyclophosphamide, and prednisone for relapsed/refractory multiple myeloma: a multicenter phase 1/2 open-label study.// Blood. - 2013. - Vol. 122, N16. - P. 2799-2806.
  • Bringhen S, Mina R, Cafro AM, et al. Once-weekly carfilzomib, pomalidomide, and low-dose dexamethasone for relapsed/ refractory myeloma: a phase I/II study// Leukemia. - 2018. - Vol. 32, N 8. - P. 1803-1807.
  • Mateos M-V, Ocio EM, Sureda Balari A, et al. Randomized Phase 2 Study ofWeekly Carfilzomib 70 Mg/m2 and Dexamethasone Plus/Minus Cyclophosphamide in Relapsed and/or Refractory Multiple Myeloma (RRMM) Patients (GEM- KyCyDex).// Blood. - 2020. - Vol. 136, Suppl 1. - P. 8-9.
  • Voorhees PM, Suman VJ, Tuchman SA, et al. A phase I/II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202)// Am J Hematol. - 2021. - Vol. 96, N. 12. - P. 1S9S-1603.
  • Jakubowiak A, Offidani M, Pégourie B, et al. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/ dexamethasone for relapsed/refractory MM.// Blood. - 2016. -Vol. 127. - P. 2833-2840.
  • Chari A., Suvannasankha A., Fay J.W. et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma// Blood. - 2017. - Vol. 130. - P. 974-81.
  • Siegel D.S., Schiller G.J., Samaras C.J. et al. Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment. // Leukemia 2020. - Vol. 34. - P. 3286-3297.
  • Siegel D.S., Dimopoulos M.A., Ludwig H. et al. Improvement in overall survival with carfilzomib, lenalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma.// J Clin Oncol. - 2018. - Vol. 36. - P. 728-734.
  • Kaufman J.L., Usmani S.Z., San-Miguel J. et al. Four year follow-up of the phase 3 POLLUX study of daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) alone in relapsed and refractory multiple myeloma// Blood. - 2019. - Vol. 134, Suppl 1. - P. 1866.
  • Meletios A. Dimopoulos, доклад на 3 конф. EMN, 6-9 апреля 2022 г.; онлайн; www.congresshub.com/Oncology/EMN2022/Daratumumab/Dimopoulos.
  • Siegel D.S., Dimopoulos M.A., Ludwig H. et al. Improvement in overall survival with carfilzomib, lenalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma// J Clin Oncol. - 2018. - Vol. 36. - P. 728-734.
  • Moreau P., Masszi T., Grzasko N. et al. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma// N Engl J Med. - 2016. - Vol. 374. - P. 1621-1634.
  • Dimopoulos M., Weisel K., Lonial S. et al. Elotuzumab plus lenalidomide/ dexamethasone for relapsed/refractory multiple myeloma: Final overall survival results from the phase 3 ELOQUENT-2 trial// 17thInternational Myeloma Workshop, Boston, September 12-15, 2019, Abstract OAB-021.
  • Dimopoulos M.A., Lonial S., White D. et al. Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study.// Blood Cancer J. - 2020. - Vol. 10. - P. 91.
  • Grosicki S., Simonova M., Spicka I. et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial// Lancet. - 2020. - Vol. 396. - P. 1563-1573.
  • Kumar S.K., Harrison S.J., Cavo M. et al. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial// Lancet Oncol. - 2020. - Vol. 21. - P. 1630-1642.
  • Orlowski R.Z., Moreau P., Niesvizky R. et al. Carfilzomib dexamethsone versus bortezomib-dexamethasone in relapsed or refractory multiple myeloma: updated overall survival, safety, and subgroups.// Clin Lymphoma Myeloma Leuk. - 2019. -Vol. 19. - P. 522-530.
  • Kumar S, Harrison S, Cavo M, et al. A phase 3 study of venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Presented at: 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, The Netherlands. Abstract LB2601.
  • Cook G., Ashcroft A.J., Cairns D.A. et al. The effect of salvage autologous stem-cell transplantation on overall survival in patients with relapsed multiple myeloma (final results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open-label, phase 3 trial// Lancet Haematol. - 2016. - Vol. 3. - P. e340-351.
  • Goldschmidt H., Baertsch M-A., Schlenzka J. et al. Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE//Leukemia. - 2021. - Vol. 35. - P. 1134-1144.
  • Sonneveld P., Zweegman S., Cavo M. et al. Carfilzomib, pomalidomide and dexamethasone (KPd) in patients with multiple myeloma refractory to bortezomib and lenalidomide. The EMN011 Trial.// Blood. - 2018. - Vol. 132, Suppl 1. - P. 801.
  • Giralt S., Garderet L., Durie B. et al. American Society of Blood and Marrow Transplantation, European Society of Blood and Marrow Transplantation, Blood and Marrow Transplant Clinical Trials Network, and International Myeloma Working Group consensus conference on salvage hematopoietic cell transplantation in patients with relapsed multiple myeloma// Biol Blood Marrow Transplant. - 2015. Vol. 21. - P. 2039-2051.
  • Rajkumar S.V., Kumar S. Multiple myeloma current treatment algorithms// Blood Cancer Journal. - 2020. - Vol. 94. - P. 2-10.
  • Miller K.C., Gertz M.A., Buadi F.K. et al. The impact of re-induction prior to salvage autologous stem cell transplantation in multiple myeloma //Bone Marrow Transplant. - 2019. - Vol. 54. - P. 2039-2050.
  • Miguel J.S., Weisel K., Moreau P. et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial// Lancet Oncol. - 2013. - Vol. 14. - P. 1055-1066.
  • Attal M, Richardson P.G., Rajkumar S.V. 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): a randomised, multicentre, open-label, phase 3 study// Lancet. - 2019. - Vol. 394. - P. 2096-2107.
  • Dimopoulos M.A., Dytfeld D., Grosicki S. et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma// N Engl J Med. - 2018. - Vol. 379. - P. 1811-1822.
  • Mateos M.V., Nahi H., Legiec W. et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial// The Lancet Haematology. - 2020. - Vol. 7. - P. e370-e380.
  • Mateos M.V., Usmani S.Z. Subcutaneous versus intravenous daratumumab in multiple myeloma// Lancet Haematol. - 2020. - Vol. 8. - P. e559.
  • Mateos M.V., Nahi H., Usmani S. et al. Efficacy and safety of the randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): COLUMBA//J Clin Oncology. - 2019. - Vol. 37, Issue 15, Suppl. Abstract 8005, ASCO Annual Meeting I.
  • Dimopoulos M.A., Terpos E., Boccadoro M. et al. Apollo: Phase 3 randomized study of subcutaneous daratumumab plus pomalidomide and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) alone in patients (Pts) with relapsed/ refractory multiple myeloma (RRMM). All-Virtual 62nd ASH Annual Meeting & Exposition; Dec 5 to Dec 8, 2020 (abstr 412).
  • Baz R.C., Martin T.G., Lin H.Y. et al. Randomized multicenter phase 2 study of pomalidomide, cyclophosphamide, and dexamethasone in relapsed refractory myeloma.// Blood. - 2016. - Vol. 127. - P. 2561-2568.
  • Kumar S.K., Lee J.H., LahuertaJ.J. et al. Risk of progression and survival in multiple myeloma relapsed after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study//Leukemia. - 2012. - Vol. 26. - P. 149157.
  • Usmani S., Ahmadi T., Ng Y. et al. Analysis of Real-World Data on Overall Survival in Multiple Myeloma Patients With > 3 Prior Lines of Therapy Including a Proteasome Inhibitor (PI) and an Immunomodulatory Drug (IMiD), or Double Refractory to a PI and an IMiD// The Oncologist. - 2016. - Vol. 21. - P. 1-7.
  • Gandhi U.H., Cornell R.F., Lakshman A. et al. Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy // Leukemia. - 2019. - Vol. 33. - P. 2266-2275.
  • Kapoor P., Ramakrishnan V., Rajkumar S.V. Bortezomib combination therapy in multiple myeloma// Semin Hematol. -2012. - Vol. 49. - P. 228-242.
  • Lokhorst H.M., Plesner T., Laubach J.P. et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma// N Engl J Med. - 2015. - Vol. 373, N 13. - P. 1207-1219.
  • Lonial S., Weiss B.M., Usmani S.Z. et al. Daratumumab monotherapy in patients with treatment refractory multiple myeloma (SIRIUS): an open-label, randomized, phase 2 trial.// Lancet. - 2016. - Vol. 387. - P. 1551-1560.
  • Usmani S.Z., Weiss B.M., Plesner T. et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma// Blood. - 2016. - Vol. 128, N 1. - P. 37-44.
  • Richardson P.G., Schlossman R.L., Alsina M. et al. PANORAMA 2: panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory myeloma// Blood. - 2013. - Vol. 122. - P. 2331-2337.
  • Chari A., Vogl D.T., Gavriatopoulou M. et al. Oral selinexor-dexamethasone for triple-class refractory multiple myeloma// N Engl J Med. - 2019. - Vol. 381. - P. 727-738.
  • Costa L., Stadtmauer E., Davies F. et al. Updated safety and efficacy from a phase 2 study of venetoclax plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Presented at: 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, The Netherlands. Abstract PS1375.
  • Richardson PG, Mateos M-V, Rodríguez-Otero P, et al. Activity of melflufen in RR MM patients with extramedullary disease in the phase 2 HORIZON Study (OP-106): promising results in a high-risk population. Presented at: 17th International Myeloma Workshop; September 12-15, 2019; Boston, MA. Abstract 904.
  • Richardson P.G., Bringhen S., Voorhees P. et al. Melflufen plus dexamethasone in relapsed and refractory multiple myeloma (O-12-M1): a multicentre, international, open-label, phase 1-2 study// Lancet Haematol. - 2020. - Vol. 7. - P. e395-407.
  • Richardson P., Oriol A., Larocca A. et al. Melflufen and dexamethasone in heavily pretreated relapsed and refractory multiple myeloma// J Clin Oncol. - 2020; published online Dec 9. https://doi.org/10.1200/jco.20.02259.
  • Pour L, Efebera YA, Granell M, et al. ANCHOR (OP-104): a phase 1 study update of melflufen and dexamethasone plus bortezomib or daratumumab in relapsed/refractory multiple myeloma patients refractory to an IMiD or a proteasome inhibitor. Presented at: 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, The Netherlands. Abstract PF608.
  • Lonial S., Niels W.C.J., van de Donk N. et al. First clinical (phase 1b/2a) study of iberdomide (CC-220; IBER), a CELMoD, in combination with dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM)//J Clin Oncol. - 2019. - Vol. 37, Suppl., ASCO Abstract 8006.
  • Amatangelo M., Gaudy A., Bjorklund C. et al. Iberdomide (CC-220) is pharmacodynamically active and has dose-dependent immunostimulatory activity in relapsed/refractory multiple myeloma patients irrespective of prior IMiD drug treatment//24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, The Netherlands. Abstract PF559.
  • Tai Y.T., Anderson K.C. B cell maturation antigen (BCMA)-based immunotherapy for multiple myeloma// Expert Opin Biol Ther. - 2019. - Vol. 19. - P. 1143-1456.
  • Trudel S, Lendvai N, Popat R, et al. Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study.// Blood Cancer J. - 2019. - Vol. 9. - P 37.
  • Popat R, Warcel D, O'Nions J, et al. Durability of response and characterization of corneal events with extended follow-up after belantamab mafodotin monotherapy for patients with relapsed/refractory multiple myeloma. Proceedings from: 17th International Myeloma Workshop; September 12-15, 2019; Boston, MA. Abstract FP-165.
  • Popat R, Opalinska JB, Eliason L, et al. Patient reported experience from part 2 of the first time in human study of the BCMA antibody drug conjugate GSK2857916 for advanced relapsed refractory multiple myeloma (DREAMM-1). Presented at: 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, The Netherlands. Abstract PS1401.
  • GlaxoSmithKline. GSK announces positive headline results from the pivotal DREAMM-2 study for multiple myeloma [press release]. https://us.gsk.com/en-us/media/press-releases/gsk-announces-positive-headline-results-from-the-pivotal-dreamm-2-study-for-multiple-myeloma/. Accessed September 6, 2019.
  • Lonial S., Lee H.C., Badros A. et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.// Lancet Oncol. - 2020. - Vol. 21. - P. 207-221.
  • Trudel S., Lendvai N., Popat R. et al. Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study// Blood Cancer J. - 2019. - Vol. 9. - P. 37.
Еще
Другой
SciUp 2024 © 2024 ©