A Registry of AL Amyloidosis (ReAL) | NCT04839003

Studies
A Registry of AL Amyloidosis (ReAL)

NCT04839003

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Recruiting

Last Update Posted

Apr 16, 2026Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

AL Amyloidosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2020Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Mar 22, 2021

First Submission Date that Met QC Criteria

Apr 7, 2021

First Posted Date

Apr 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Palladini, Principal Investigator, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Detailed Description

Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Creation of a registry of patients with AL amyloidosis		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of systemic AL amyloidosis;
treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
age ≥18 years;
ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
planned (or ongoing) follow-up at participating center.

Exclusion Criteria:

non-AL amyloidosis;
previous treatment for AL amyloidosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Policlinico San Matteo	Recruiting	Pavia		27100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000075363	Immunoglobulin Light-chain Amyloidosis
D000686	Amyloidosis

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D057165	Proteostasis Deficiencies

Browse Leaves

Not provided

Browse Branches

Not provided

Description

It will be generated a biobank of body fluids (serum, plasma, urine) and relevant cellular (bone marrow and peripheral blood mononuclear cells) and tissue samples (bone marrow, periumbilical fat, possibly other biopsied organs) from patients with AL amyloidosis. We will obtain research samples from diagnostic leftovers of consenting patients at diagnosis and at each subsequent visit.