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Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy

机译:阿哌沙班用于接​​受免疫调节治疗的多发性骨髓瘤患者的静脉血栓栓塞的一级预防

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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.
机译:包括沙利度胺,来那度胺和泊马利度胺在内的免疫调节药物(IMiDs)改善了多发性骨髓瘤(MM)患者的生存率。但是,这些疗法与静脉血栓栓塞(VTE)的风险增加有关。阿哌沙班已被批准用于治疗急性VTE和降低初始治疗后复发VTE的风险。在此IV期单臂研究(NCT02958969)中,我们旨在前瞻性评估apixaban对MM患者进行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个月内症状性VTE的发生率,包括深静脉血栓形成(DVT)和肺栓塞(PE)。主要安全目标是确定接受阿哌沙班预防的MM患者的大出血率。如果被证明是安全有效的,阿哌沙班将成为预防MM患者口服VTE的有前途的选择。

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