Division of Hematology and Oncology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Br J Haematol. 2020 Aug;190(4):555-561. doi: 10.1111/bjh.16653. Epub 2020 Apr 21.
Immunomodulatory drugs (IMiDs) have improved survival of patients with multiple myeloma (MM) and comprise the therapeutic backbone at all phases of therapy. Although well-tolerated, IMiDs increase rates of venous thromboembolism (VTE). In this phase IV, single-arm pilot study, fifty patients with MM on IMiDs received apixaban 2·5 mg orally twice daily for primary prevention of VTE and were prospectively monitored for six months. The primary safety outcomes were rates of major haemorrhage and clinically relevant non-major haemorrhage over six months. The primary efficacy outcome was the rate of symptomatic VTE over six months. IMiDs used were lenalidomide (58%) or pomalidomide (42%). During the six-month evaluation period, no patients experienced major haemorrhage or VTE. Three patients experienced clinically relevant, non-major haemorrhage which was managed medically, and all were able to resume apixaban. One patient stopped therapy shortly after initiation due to an allergic reaction to apixaban. No patients experienced stroke, myocardial infarction, or death. In this pilot study, low-dose apixaban was safe and well-tolerated as a primary prevention therapy of VTE for patients with MM receiving IMiDs. Further studies are needed to validate low-dose apixaban as a standard primary prevention anti-thrombotic strategy for patients with MM receiving IMiDs.
免疫调节药物（IMiDs）改善了多发性骨髓瘤（MM）患者的生存，并且构成了治疗的主要支柱。虽然耐受性良好，但 IMiDs 会增加静脉血栓栓塞（VTE）的发生率。在这项 IV 期、单臂、初步研究中，50 名接受 IMiDs 治疗的 MM 患者每天口服两次 2.5 毫克阿哌沙班，用于 VTE 的一级预防，并在 6 个月内进行前瞻性监测。主要安全性结局是 6 个月内大出血和临床相关非大出血的发生率。主要疗效结局是 6 个月内有症状的 VTE 发生率。所使用的 IMiDs 为来那度胺（58%）或泊马度胺（42%）。在 6 个月的评估期内，没有患者发生大出血或 VTE。3 名患者发生了临床相关的非大出血，经药物治疗后得到控制，所有患者均能够恢复使用阿哌沙班。1 名患者因对阿哌沙班过敏而在开始治疗后不久停药。没有患者发生中风、心肌梗死或死亡。在这项初步研究中，低剂量阿哌沙班作为接受 IMiDs 治疗的 MM 患者 VTE 的一级预防治疗是安全且耐受良好的。需要进一步的研究来验证低剂量阿哌沙班作为接受 IMiDs 治疗的 MM 患者标准的一级预防抗血栓策略的有效性。
