无丙二醇美法仑作为骨髓瘤自体移植的预处理方案
Propylene glycol-free melphalan as conditioning regimen for autologous transplantation in myeloma.
作者信息
Aljitawi Omar S, Hari Parameswaran
机构信息
Blood & Marrow Transplant Program, Department of Internal Medicine, Division of Hematologic Malignancies & Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS 66160, USA.
Department of Medicine, Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
出版信息
Int J Hematol Oncol. 2016 May;5(1):5-10. doi: 10.2217/ijh-2015-0006. Epub 2016 May 31.
Abstract
High-dose melphalan has been the drug of choice for preparative regimens for autologous stem cell transplantation in multiple myeloma. Propylene-free melphalan (Evomela™) is a newer formulation of melphalan, which incorporates Captisol to produce a stable product upon reconstitution. In addition to avoiding propylene glycol with its' potential side effects, this approach improves the overall stability of reconstituted melphalan and can ensure intended dose delivery. In this paper, we review the published literature regarding this formulation. We focus on its' chemistry, pharmacokinetics and clinically available data for its use in myeloma autologous stem cell transplantation setting.
摘要
大剂量美法仑一直是多发性骨髓瘤自体干细胞移植预处理方案的首选药物。无丙二醇美法仑（Evomela™）是美法仑的一种新型制剂，它加入了Captisol以在复溶后产生稳定的产品。除了避免丙二醇及其潜在的副作用外，这种方法还提高了复溶后美法仑的整体稳定性，并能确保准确给药。在本文中，我们回顾了关于该制剂的已发表文献。我们重点关注其化学性质、药代动力学以及在骨髓瘤自体干细胞移植环境中使用的临床可用数据。
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A Phase IIb, Multicenter, Open-Label, Safety, and Efficacy Study of High-Dose, Propylene Glycol-Free Melphalan Hydrochloride for Injection (EVOMELA) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation.一项关于注射用高剂量、无丙二醇美法仑（EVOMELA）用于接受自体移植的多发性骨髓瘤患者清髓预处理的IIb期、多中心、开放标签、安全性和有效性研究。
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