Hanna Löffler, Magdalena Braun, Heike Reinhardt, Amelie Rösner, Gabriele Ihorst, Jan Räder, Sina Wenger, Annamaria Brioli, Marie von Lilienfeld-Toal, Maika Klaiber-Hakimi, Eva-Marie Fehr, Markus Munder, Katharina Epp, Karolin Trautmann-Grill, Sarah Decker, Holger Hoff, Ralph Wäsch, Monika Engelhardt
{"title":"伊沙唑米-来那度米-地塞米松(IRd)治疗复发性难治性多发性骨髓瘤(RRMM)——来自德国的多中心真实世界分析和文献比较回顾","authors":"Hanna Löffler, Magdalena Braun, Heike Reinhardt, Amelie Rösner, Gabriele Ihorst, Jan Räder, Sina Wenger, Annamaria Brioli, Marie von Lilienfeld-Toal, Maika Klaiber-Hakimi, Eva-Marie Fehr, Markus Munder, Katharina Epp, Karolin Trautmann-Grill, Sarah Decker, Holger Hoff, Ralph Wäsch, Monika Engelhardt","doi":"10.1007/s00277-025-06441-8","DOIUrl":null,"url":null,"abstract":"<p><p>With the introduction of novel agents (proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), immuntherapeutics), the outcome of multiple myeloma (MM) patients has improved. The oral PI ixazomib was authorized in the EU in 11/2016 and is indicated in combination with lenalidomide and dexamethasone (IRd) for the treatment of patients with relapsed/refractory MM (RRMM). The study aim was to identify the typical real world (RW) RRMM patient population in Germany treated with IRd and to compare the outcome to prior IRd cohorts. Our retrospective study included consecutive RRMM patients receiving IRd in six large German hospitals between 06/2017 and 12/2021. We identified 24 consecutive RRMM patients within these six institutions. Their median age was 68 years at the start of IRd; 21% carrying high-risk cytogenetics [del17p, t(4;14) and/or t(14;16)]. Patients had a median of 2 prior treatment lines (range, 1-5), prior PI/IMiD exposure was 100%/58%, comparable to previous real world evidence (RWE)-studies. With a median follow-up of 37.7 months, the overall response rate was 70.8%, and median PFS and OS were 22.0 and 62.2 months, respectively. With these German data, our study is closing an important gap of IRd real world data (RWD) reporting across Europe, providing median PFS/OS data and comparison to prior IRd studies. IRd is a well-tolerated and effective triplet regimen, often given as 2nd or 3rd-line therapy in RRMM, with results confirming the registration trial and other international RW-analyses.</p>","PeriodicalId":8068,"journal":{"name":"Annals of Hematology","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ixazomib-lenalidomid-dexamethasone (IRd) in relapsed refractory multiple myeloma (RRMM)-multicenter real-world analysis from Germany and comparative review of the literature.\",\"authors\":\"Hanna Löffler, Magdalena Braun, Heike Reinhardt, Amelie Rösner, Gabriele Ihorst, Jan Räder, Sina Wenger, Annamaria Brioli, Marie von Lilienfeld-Toal, Maika Klaiber-Hakimi, Eva-Marie Fehr, Markus Munder, Katharina Epp, Karolin Trautmann-Grill, Sarah Decker, Holger Hoff, Ralph Wäsch, Monika Engelhardt\",\"doi\":\"10.1007/s00277-025-06441-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>With the introduction of novel agents (proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), immuntherapeutics), the outcome of multiple myeloma (MM) patients has improved. The oral PI ixazomib was authorized in the EU in 11/2016 and is indicated in combination with lenalidomide and dexamethasone (IRd) for the treatment of patients with relapsed/refractory MM (RRMM). The study aim was to identify the typical real world (RW) RRMM patient population in Germany treated with IRd and to compare the outcome to prior IRd cohorts. Our retrospective study included consecutive RRMM patients receiving IRd in six large German hospitals between 06/2017 and 12/2021. We identified 24 consecutive RRMM patients within these six institutions. Their median age was 68 years at the start of IRd; 21% carrying high-risk cytogenetics [del17p, t(4;14) and/or t(14;16)]. Patients had a median of 2 prior treatment lines (range, 1-5), prior PI/IMiD exposure was 100%/58%, comparable to previous real world evidence (RWE)-studies. With a median follow-up of 37.7 months, the overall response rate was 70.8%, and median PFS and OS were 22.0 and 62.2 months, respectively. With these German data, our study is closing an important gap of IRd real world data (RWD) reporting across Europe, providing median PFS/OS data and comparison to prior IRd studies. IRd is a well-tolerated and effective triplet regimen, often given as 2nd or 3rd-line therapy in RRMM, with results confirming the registration trial and other international RW-analyses.</p>\",\"PeriodicalId\":8068,\"journal\":{\"name\":\"Annals of Hematology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-06-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Hematology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00277-025-06441-8\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Hematology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00277-025-06441-8","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Ixazomib-lenalidomid-dexamethasone (IRd) in relapsed refractory multiple myeloma (RRMM)-multicenter real-world analysis from Germany and comparative review of the literature.
With the introduction of novel agents (proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), immuntherapeutics), the outcome of multiple myeloma (MM) patients has improved. The oral PI ixazomib was authorized in the EU in 11/2016 and is indicated in combination with lenalidomide and dexamethasone (IRd) for the treatment of patients with relapsed/refractory MM (RRMM). The study aim was to identify the typical real world (RW) RRMM patient population in Germany treated with IRd and to compare the outcome to prior IRd cohorts. Our retrospective study included consecutive RRMM patients receiving IRd in six large German hospitals between 06/2017 and 12/2021. We identified 24 consecutive RRMM patients within these six institutions. Their median age was 68 years at the start of IRd; 21% carrying high-risk cytogenetics [del17p, t(4;14) and/or t(14;16)]. Patients had a median of 2 prior treatment lines (range, 1-5), prior PI/IMiD exposure was 100%/58%, comparable to previous real world evidence (RWE)-studies. With a median follow-up of 37.7 months, the overall response rate was 70.8%, and median PFS and OS were 22.0 and 62.2 months, respectively. With these German data, our study is closing an important gap of IRd real world data (RWD) reporting across Europe, providing median PFS/OS data and comparison to prior IRd studies. IRd is a well-tolerated and effective triplet regimen, often given as 2nd or 3rd-line therapy in RRMM, with results confirming the registration trial and other international RW-analyses.
期刊介绍:
Annals of Hematology covers the whole spectrum of clinical and experimental hematology, hemostaseology, blood transfusion, and related aspects of medical oncology, including diagnosis and treatment of leukemias, lymphatic neoplasias and solid tumors, and transplantation of hematopoietic stem cells. Coverage includes general aspects of oncology, molecular biology and immunology as pertinent to problems of human blood disease. The journal is associated with the German Society for Hematology and Medical Oncology, and the Austrian Society for Hematology and Oncology.