NCT04937777

A Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe

A Retrospective Observational Multicenter Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,481 (actual)
• Sponsor: European Myeloma Network B.V. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations.

Detailed description

The lack of regulatory approved treatment options for AL amyloidosis (AL-AMY) justifies the need to understand the current treatment practice and outcomes of this disease. There is a need for objective Real-World Evidence (RWE) that reflects how treatments are initiated, combined and sequenced, and how their relative effectiveness and safety profiles emerge outside a clinical trial setting. Therefore, the aim is to generate RWE on systemic AL-AMY patients in Europe, including patient characteristics, resource use, treatments and associated patient outcomes.

Conditions

• AL Amyloidosis

Timeline

• Start date: 2019-04-23
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2021-06-24
• Last updated: 2022-09-27

Locations

13 sites across 10 countries: Austria, Czechia, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom