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Continuous lenalidomide treatment after bortezomib-melphalan-prednisolone therapy for newly diagnosed multiple myeloma.
Annals of Hematology ( IF 3.5 ) Pub Date : 2020-04-04 , DOI: 10.1007/s00277-020-03988-6
Tadao Ishida 1, 2 , Hideo Kimura 3 , Shuji Ozaki 4 , Koumei Kubo 5 , Kazutaka Sunami 6 , Naoki Takezako 7 , Hiroyuki Fujita 8 , Toshiaki Hayashi 2, 9 , Toru Kiguchi 10 , Kazuteru Ohashi 11 , Satoshi Yamamoto 12 , Hiroyuki Takamatsu 13 , Hiroshi Kosugi 14 , Kensuke Ohta 15 , Rika Sakai 16 , Hiroshi Handa 17 , Seiji Kondo 18 , Yu Abe 1 , Eijiro Omoto 19 , Kinuko Mitani 20 , Satoshi Morita 21 , Hirokazu Murakami 22 , Kazuyuki Shimizu 23
Affiliation  

These are the results of phase II study of bortezomib-melphalan-prednisolone (VMP) induction therapy followed by lenalidomide-dexamethasone (Rd) consolidation and lenalidomide maintenance in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), overall response rates (ORRs), and safety. Eighty-three eligible patients were enrolled between October 2012 and August 2014. The median PFS was 28.0 months (95% CI 19.6-36.7) and the median OS was 55.3 months (95% CI 51.6-NA). Among the patients who received lenalidomide maintenance therapy, median PFS was significantly improved in patients who had achieved a very good partial response (VGPR) or better (41.8 vs 20.7 months, p = 0.0070). As the best response, the rates of partial response or better were 85.5% comprising stringent complete response (sCR, 21.7%), complete response (CR, 10.8%), VGPR (18.1%), and partial response (PR, 34.9%). The most frequently observed grade 3 or higher adverse events during the VMP therapy were anemia (28.9%), neutropenia (15.6%), thrombocytopenia (6.0%), and peripheral neuropathy (2.4%). The most frequently observed grade 3 or higher adverse events during the Rd therapy were anemia (3.5%), neutropenia (1.8%), and skin rush (5.3%). The most frequently observed grade 3 or higher adverse events during lenalidomide maintenance therapy were anemia (7.4%) and neutropenia (24.1%). Thus, VMP induction therapy followed by Rd consolidation and lenalidomide maintenance is considered a well-tolerated and effective regimen in transplant-ineligible NDMM. This trial is registered with UMIN-CTR with the identification number UMIN000009042.

中文翻译:

硼替佐米-美法仑-泼尼松龙治疗后连续来那度胺治疗新诊断的多发性骨髓瘤。

这些是硼替佐米-美法仑-泼尼松龙(VMP)诱导治疗,来那度胺-地塞米松(Rd)合并和来那度胺维持治疗不适合移植的新诊断多发性骨髓瘤(NDMM)患者的II期研究结果。主要终点是无进展生存期(PFS)。次要终点包括总生存期(OS),总缓解率(ORR)和安全性。在2012年10月至2014年8月之间招募了83例合格患者。中位PFS为28.0个月(95%CI 19.6-36.7),中位OS​​为55.3个月(95%CI 51.6-NA)。在接受来那度胺维持治疗的患者中,达到很好的部分缓解(VGPR)或更好的患者的中位PFS明显改善(41.8 vs 20.7个月,p = 0.0070)。作为最佳回应,部分缓解或更高的比率为85.5%,其中包括严格的完全缓解(sCR,21.7%),完全缓解(CR,10.8%),VGPR(18.1%)和部分缓解(PR,34.9%)。VMP治疗期间最常观察到的3级或更高级别的不良事件是贫血(28.9%),中性粒细胞减少症(15.6%),血小板减少症(6.0%)和周围神经病(2.4%)。Rd治疗期间最常观察到的3级或更高级别的不良事件是贫血(3.5%),中性粒细胞减少症(1.8%)和皮疹(5.3%)。来那度胺维持治疗期间最常观察到的3级或更高的不良事件是贫血(7.4%)和中性粒细胞减少症(24.1%)。因此,在不适合移植的NDMM中,VMP诱导疗法,Rd巩固和来那度胺维持被认为是一种耐受良好且有效的方案。
更新日期:2020-04-04
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