在多发性骨髓瘤中使用贝兰他马布 (Belantamab Mafodotin),波马利多米德 (Pomalidomide) 和甲 (Dexamethasone)
Meletios Athanasios Dimopoulos1, Meral Beksac1, Ludek Pour1
1From the Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens (M.A.D.), and General Hospital Evangelismos (S.D.) - both in Athens; the Department of Hematology, Ankara Liv Hospital, Istinye University, Ankara, Turkey (M.B.); the Department of Internal Medicine, Hematology, and Oncology, University Hospital Brno, Brno (L.P.), the First Faculty of Medicine, Charles University, and General Hospital, Prague (I.S.), and the Fourth Department of Internal Medicine-Hematology, University Hospital Hradec Králové, and Faculty of Medicine in Hradec Králové, Charles University, Hradec Králové (J.R.) - all in the Czech Republic; Leningrad Regional Clinical Hospital, Saint Petersburg, Russia (V.V.); the University of Melbourne, St. Vincent's Hospital, Melbourne, VIC, Australia (H.Q.); Medical University of Lodz, Łódź, Poland (P.R.); Sungkyunkwan University and Samsung Medical Center, Seoul, South Korea (K.K.); IRCCS Azienda Ospedaliero-Universitaria di Bologna, Seràgnoli Institute of Hematology, and Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy (M.C.); the Division of Clinical Oncology-Hematology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo (K.S.); GSK, Durham, NC (K.M.); GSK, Philadelphia (F.P.), and GSK, Collegeville (N.S., B.E.K., J.O.) - both in Pennsylvania; GSK, Stevenage, United Kingdom (A.P.-J.); GSK, Waltham, MA (X.L.Z., G.F.); the Hematology Department, Cancer Research Center-Instituto de Investigación Biomédica de Salamanca, University Hospital of Salamanca, Salamanca, Spain (M.-V.M.); and the Department of Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto (S.T.).
与波马利多米德,博特佐米布和甲 (PVd) 相比,贝兰塔马布对复发性或耐药性多发性骨髓瘤患者的无进展生存率显著改善. BPd显示出更深层次,更持久的反应,眼部事件可控.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 多重骨髓瘤治疗包括蛋白酶体抑制剂,免疫调节剂和抗CD38抗体改善了生存率,但复发很常见.
- 前线的莱纳利多米德治疗导致了莱纳利多米德耐药性多发性骨髓瘤患者在第一次复发时的增加.
研究的目的:
- 为了评估贝兰塔马布的有效性和安全性mfodotin,波马利多米德和德克萨米松 (BPd) 与波马利多米德,博尔特佐米布和德克萨米松 (PVd) 在患有复发性或耐火性多发性骨髓瘤的患者之前暴露于lenalidomide.
主要方法:
- 一个第三阶段,随机的,开放的标签试验,比较了 lenalidomide 暴露的复发性或耐火性多发性髓瘤患者的 BPd 和 PVd.
- 主要终点是无进展生存期;次要终点包括疾病反应和安全性评估.
主要成果:
- BPd显示12个月无进展生存率为71%相比PVD为51% (危险比0.52;P<0.001).
- 对BPd的响应率为77%,对PVD的响应率为72%,对BPd的完整响应率或更好的响应率为40%,对PVD的响应率为16%.
- 3级或更高的不良事件发生在94%的BPd患者和76%的PVD患者中;眼部事件在BPd患者中更频繁,但通过剂量修改可以控制.
结论:
- 在暴露于莱纳利多米德的复发性或耐火性多发性髓瘤中,BPd提供了显著的无进展生存益处,并且比PVd更深刻,更持久的反应.
- 与BPd相关的眼部事件很常见,但可以通过剂量修改控制,这表明可以管理的安全性.
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