Introduction

Lenalidomide plus dexamethasone is effective and well tolerated in relapsed/refractory multiple myeloma (RRMM). In this observational, noninterventional European post-authorization safety study, the safety profile of lenalidomide plus dexamethasone was investigated and compared with that of other agents in the treatment of RRMM in a real-world setting.

Patients and Methods

Patients had received ≥ 1 prior antimyeloma therapy; prior lenalidomide was excluded. Treatment was per investigator’s routine practice. Adverse events were analyzed by incidence rates per 100 person-years to account for differences in observation length and treatment duration.

Results

In total, 2150 patients initiated lenalidomide, and 1479 initiated any other antimyeloma therapy, predominately bortezomib (80.3%), which was primarily administered intravenously (74.3%). The incidence rate of neuropathy was lower with lenalidomide (10.5) than with bortezomib (78.9) or thalidomide (38.7). Lenalidomide also had a lower incidence rate of infections (68.7) versus bortezomib (95.9) and thalidomide (76.0). Conversely, the incidence rate of neutropenia was higher with lenalidomide (38.0) than with bortezomib (18.2) or thalidomide (25.7). The incidence rates of thrombocytopenia were 24.4, 40.4, and 14.4 with lenalidomide, bortezomib, and thalidomide, respectively.

Conclusion

No new safety signals for lenalidomide were identified in this study, which is the largest prospective real-world European study of lenalidomide in patients with RRMM to date. These results confirm that the safety profile of lenalidomide plus dexamethasone in RRMM in a real-world setting is comparable to that reported in clinical trials.

中文翻译：

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一项针对接受来那度胺治疗的复发性/难治性多发性骨髓瘤患者的非干预性、观察性、欧洲授权后安全性研究。

介绍

来那度胺加地塞米松治疗复发/难治性多发性骨髓瘤 (RRMM) 有效且耐受性良好。在这项观察性的、非干预性的欧洲授权后安全性研究中，对来那度胺加地塞米松的安全性进行了调查，并在现实环境中与其他药物治疗 RRMM 的安全性进行了比较。

患者和方法

患者既往接受过≥1次抗骨髓瘤治疗；先前的来那度胺被排除在外。治疗按照研究者的常规做法进行。不良事件按每 100 人年的发生率进行分析，以解释观察时间和治疗持续时间的差异。

结果

总共有 2150 名患者开始使用来那度胺，1479 名开始任何其他抗骨髓瘤治疗，主要是硼替佐米 (80.3%)，主要是静脉给药 (74.3%)。来那度胺 (10.5) 的神经病变发生率低于硼替佐米 (78.9) 或沙利度胺 (38.7)。与硼替佐米 (95.9) 和沙利度胺 (76.0) 相比，来那度胺的感染发生率 (68.7) 也较低。相反，来那度胺 (38.0) 的中性粒细胞减少发生率高于硼替佐米 (18.2) 或沙利度胺 (25.7)。来那度胺、硼替佐米和沙利度胺的血小板减少症发生率分别为 24.4、40.4 和 14.4。

结论

在这项研究中没有发现来那度胺的新安全性信号，这是迄今为止欧洲最大的来那度胺治疗 RRMM 患者的前瞻性真实世界研究。这些结果证实，来那度胺加地塞米松在真实世界环境中的 RRMM 中的安全性与临床试验中报告的安全性相当。