关于皮下注射达雷妥尤单抗联合硼替佐米、沙利度胺和地塞米松用于新诊断的适合移植的多发性骨髓瘤患者的真实世界数据。
Real-world data on the use of subcutaneous daratumumab plus bortezomib, thalidomide, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.
作者信息
Hungria Vania, Moura Fernanda Lemos, Costa Abel, Ribeiro Eduardo Flávio Oliveira, Soares Paulo, Lima Juliana Souza, Ricci Lisa Aquaroni, Arrais-Rodrigues Celso, Nucci Fabio Moore, de Moraes Lima Marinus, de Magalhães Filho Roberto Jose Pessoa, Bhaumik Amitabha, Parekh Trilok, Borgsten Fredrik, Carson Robin, Trufelli Damila C, de Queiroz Crusoe Edvan
机构信息
Clinica São Germano, Rua Comendador Miguel Calfat 165, São Paulo, SP, 04537-080, Brazil.
Fundação Antonio Prudente - AC Camargo Cancer Center, São Paulo, SP, Brazil.
出版信息
Ann Hematol. 2025 Apr 30. doi: 10.1007/s00277-025-06365-3.
Subcutaneous daratumumab in combination with bortezomib, thalidomide, and dexamethasone (D-VTd), is approved for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). However, additional real-world data are needed to assess the effectiveness and safety of D-VTd in routine clinical practice. We conducted a noninterventional, multicenter, observational study across hematology centers in Brazil to gather real-world data on D-VTd in patients with NDMM who were eligible for autologous stem cell transplant (ASCT). Eligible patients must have completed 1 or more cycle of D-VTd, on or before September 30, 2022, to be included. Data were collected retrospectively from the start of D-VTd to the study inclusion visit using patient medical records and prospectively thereafter using electronic case report forms. As of the data cutoff (August 8, 2023), 49 patients were included. By the end of consolidation, 91.7% of patients achieved an overall response (partial response or better) and 89.6% achieved very good partial response or better. Forty-five (91.8%) patients underwent stem cell mobilization with a median stem cell yield of 5.7 × 10 CD34+ cells/kg, and 44 (89.8%) patients underwent ASCT, among whom 43 out of 44 (97.7%) successfully completed ASCT. D-VTd was well tolerated, with a safety profile consistent with that previously known for daratumumab and VTd. Grade 3/4 neutropenia/febrile neutropenia and infections were reported in 32.7% and 18.4% of patients, respectively. Overall, results were consistent with the established profile of D-VTd, and these real-world effectiveness and safety results support the frontline use of subcutaneous daratumumab plus VTd in transplant-eligible patients with NDMM.
皮下注射达雷妥尤单抗联合硼替佐米、沙利度胺和地塞米松(D-VTd)已被批准用于适合移植的新诊断多发性骨髓瘤(NDMM)患者。然而,需要更多真实世界的数据来评估D-VTd在常规临床实践中的有效性和安全性。我们在巴西的血液学中心进行了一项非干预性、多中心观察性研究,以收集适合自体干细胞移植(ASCT)的NDMM患者使用D-VTd的真实世界数据。符合条件的患者必须在2022年9月30日或之前完成1个或更多周期的D-VTd治疗才能被纳入。数据从D-VTd治疗开始时使用患者病历进行回顾性收集,之后使用电子病例报告表进行前瞻性收集。截至数据截止日期(2023年8月8日),共纳入49例患者。巩固治疗结束时,91.7%的患者获得了总体缓解(部分缓解或更好),89.6%的患者获得了非常好的部分缓解或更好。45例(91.8%)患者进行了干细胞动员,中位干细胞产量为5.7×10个CD34+细胞/kg,44例(89.8%)患者接受了ASCT,其中44例中有43例(97.7%)成功完成了ASCT。D-VTd耐受性良好,其安全性与先前已知的达雷妥尤单抗和VTd一致。分别有32.7%和18.4%的患者报告了3/4级中性粒细胞减少/发热性中性粒细胞减少和感染。总体而言,结果与D-VTd已确立的特征一致,这些真实世界的有效性和安全性结果支持皮下注射达雷妥尤单抗加VTd在适合移植的NDMM患者中的一线使用。