ClinicalTrials.gov record NCT04839003

A Registry of AL Amyloidosis (ReAL)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 99 years old
SexAll
LocationItaly
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This study creates a registry of adults with systemic AL amyloidosis followed at participating centers. It collects clinical data at diagnosis and during follow-up, including retrospective pre-treatment data when available. The registry aims to describe disease course and help define and validate prognostic models and response and relapse criteria.

What it is studying. Collecting real-world clinical information to describe the natural history of systemic AL amyloidosis and to define and validate prognostic models and response and relapse criteria usable at any point in the disease.

What the researchers hope to learn. To create a large registry of patients with AL amyloidosis to describe natural history, and to define and validate prognostic models and response and relapse criteria.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would give permission for your clinical records to be entered into a research registry. The study collects information from diagnosis and from routine follow-up visits; pre-treatment records may be added for the retrospective portion. This is an observational registry—no study-assigned treatments are provided. The registry does not list any study-assigned tests or procedures beyond routine clinical care; check the consent form or ask the study team about any study-specific tests. Data may be kept for up to five years.

How the study is structured. A prospective observational registry (cohort). Clinical data are entered into a database at diagnosis and over follow-up, with a target data-collection period of five years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 27, 2020
Primary completion
May 2027 (estimated)
Study completion
May 2027 (estimated)
Target enrollment
5000 participants (estimated)
Last updated on registry
Apr 16, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Principal investigator
Giovanni Palladini, Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
treatment-naïve
Has not previously received the treatment, or the type of treatment, that the study is about.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
relapse
A condition that improved with treatment and has since returned or worsened.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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