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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4481 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-23

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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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

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AL Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group pre-2010

Patients who initiated first-line treatment between 2004 and 2010 (pre-2010).

No interventions assigned to this group

Group post-2010

Patients who initiated first-line treatment between 2011 and 2018 (post-2010).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years
* Confirmed diagnosis of AL-AMY and symptomatic organ involvement.
* Initiated first line treatment for AL-AMY in the period 2004-2018.
* Patients who have signed a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements.

The inclusion of deceased subjects in the study is permitted under the condition that consent waiver has been granted by the Scientific Committee and/or Administrative Board of the participating sites and/or any applicable regulatory body, as per local regulations, to either implement a hospital informed consent form (ICF) already in place or provide written approval of this study-specific waiver. In the occasion that waiver of consent is not granted deceased subjects will not be enrolled in the study.