European Post-Authorization Safety Study of Patients With Relapsed or Refractory Multiple Myeloma Treated With Pomalidomide in a Real-World Setting

CLINICAL LYMPHOMA MYELOMA & LEUKEMIA(2019)

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摘要
In the European Union (EU), pomalidomide (POM) is approved in combination with dexamethasone (August 2013) for the treatment (Tx) of relapsed or refractory multiple myeloma (RRMM) patients (pts) who have received at least 2 prior Tx regimens, including lenalidomide and bortezomib. RRMM pts are at an increased risk for adverse events (AEs) due to prior exposure to multiple lines of Tx and high disease burden. The POM EU post-authorization safety study (PASS; NCT02164955) is an observational, non-interventional registry designed to characterize the safety profile of POM-based Tx in RRMM pts in a real-world setting.
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关键词
Pomalidomide,real-world evidence,relapsed/refractory multiple myeloma
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