Cornell Robert Frank, Goldhaber Samuel Z, Engelhardt Brian G, Moslehi Javid, Jagasia Madan, Patton Daryl, Harrell Shelton, Hall Robert, Wyatt Houston, Piazza Greg
Division of Hematology and Oncology, Department of Medicine, Vanderbilt University Medical Center Nashville, TN, United States.
Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School Boston, MA, United States.
Front Oncol. 2019 Feb 26;9:45. doi: 10.3389/fonc.2019.00045. eCollection 2019.
Immunomodulatory drugs (IMiDs), including thalidomide, lenalidomide, and pomalidomide, have improved survival of patients with multiple myeloma (MM). However, these therapies are associated with an increased risk of venous thromboembolism (VTE). Apixaban has been approved for treatment of acute VTE and for risk reduction of recurrent VTE following initial therapy. In this phase IV single-arm study (NCT02958969), we aim to prospectively evaluate the safety and efficacy of apixaban for primary prevention of VTE in patients with MM. The primary efficacy objective of this trial is to determine the rate of symptomatic VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), over 6 months. The primary safety objective is to determine the rate of major bleeding in MM patients receiving apixaban prophylaxis. If proven safe and effective, apixaban will emerge as a promising option for oral VTE prophylaxis in MM patients.
免疫调节药物（IMiDs），包括沙利度胺、来那度胺和泊马度胺，已提高了多发性骨髓瘤（MM）患者的生存率。然而，这些疗法与静脉血栓栓塞（VTE）风险增加相关。阿哌沙班已被批准用于治疗急性VTE以及在初始治疗后降低复发性VTE的风险。在这项IV期单臂研究（NCT02958969）中，我们旨在前瞻性评估阿哌沙班对MM患者VTE一级预防的安全性和有效性。该试验的主要疗效目标是确定6个月内有症状VTE（包括深静脉血栓形成（DVT）和肺栓塞（PE））的发生率。主要安全性目标是确定接受阿哌沙班预防的MM患者的大出血发生率。如果经证实安全有效，阿哌沙班将成为MM患者口服VTE预防的一个有前景的选择。
