ClinicalTrials.gov record NCT05093153

Spanish Registry of Patients With IgM Monoclonal Gammopathies

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

Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.

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 and older
SexAll
LocationSpain
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 retrospective observational study builds a national registry of people in Spain diagnosed with IgM-MGUS or Waldenström's macroglobulinemia over the past 30 years. Investigators will collect clinical, laboratory, treatment and outcome information from medical records. The study will analyze patient characteristics, treatment patterns, long-term safety and efficacy of therapies, and overall survival.

What it is studying. Builds a national registry and analyzes clinical features, treatments, long-term safety and efficacy, and overall survival in people diagnosed with IgM-MGUS or Waldenström's macroglobulinemia in Spain over the past 30 years.

What the researchers hope to learn. Create a national database of IgM-MGUS and Waldenström's cases in Spain; describe clinical and laboratory features; evaluate long-term safety and efficacy of different treatments from past records; estimate prognosis and overall survival; inform future therapeutic strategies and clinical trials in Spain.

What this study is about

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

Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disorder which is defined by bone marrow infiltration by small lymphocytes, lymphoplasmacytoid and plasma cells together with the presence of a detectable monoclonal immunoglobulin M (IgM).The clinical presentation of WM is variable. Symptoms can be related to tumor infiltration, or they can be related to the monoclonal IgM component. The therapeutic options are heterogeneous and there are no well-established in both first line or relapse/refractory settings. In Spain, the incidence of MGUS-IgM and WM in the last decade is unknown. The aims of this retrospective, observational, multicentric study is:

  • To develop a national registry of patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance -IgM in Spain in the past 30years.
  • To evaluate the most relevant clinical characteristics, long-term safety and efficacy of different therapeutic schemes and long-term prognosis of patients with WM
  • To help in the design of future therapeutic strategies, risk prognostic factors and clinical trials in Spain.

Methods: The investigators will collect data from the patient clinical files after prior Informed Consent providing from patients with diagnosis of MGUS-IgM and WM in the past 30 years in Spain, according to the WHO classification of lymphoid tumors (2008) revised in 2016. Data from patients not able to provide IC (i.e., already dead patients) will be included only after the permission of the ethics review board. The collected data will be included in a database of the Spanish Myeloma and Lymphoma Intergroup (SMALI) team created ad-hoc by the Spanish Society of Hematology and Hemotherapy (SEHH). Each principal investigator in each center will conduct their technical supervision. The evaluation of the treatment protocols will be done following the indications of the intergroup committee according to the guidelines of the International Waldenström's Macroglobulinemia Group.

Eligibility

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

Inclusion criteria

  • Age ≥18 years
  • Patients having a confirmed diagnosis of either in the las 30 years:
  • Monoclonal Gammopathy of uncertain significance -IgM
  • Asymptomatic Waldenström's macroglobulinemia
  • Symptomatic Waldenström's macroglobulinemia

Exclusion criteria

  • Other subtypes of Lymphoproliferative diseases.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

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 be asked to give informed consent and allow the study team to collect information from your existing medical records. The team will extract past clinical data (diagnosis details, treatments, outcomes and follow-up) and enter it into a registry database. For people unable to consent (for example, already deceased), their records would be included only after ethics committee approval.

How the study is structured. Retrospective, observational registry study. Investigators collect existing medical-record data from adults diagnosed in the past 30 years across multiple centers and enter those data into a central database for analysis of outcomes such as overall survival.

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 Spain. 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 Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 1, 2021
Primary completion
March 2030 (estimated)
Study completion
March 2030 (estimated)
Target enrollment
1000 participants (estimated)
Last updated on registry
Feb 23, 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
Fundación Española de Hematología y Hemoterapía

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (51)

  • Hospital de MéridaRecruiting

    Mérida, Badajoz, 06800 · Spain

  • Hospital Son LlatzerRecruiting

    Palma, Balearic Islands · Spain

    • Joan Bargay, MD
  • Hospital Universitario Son EspasesRecruiting

    Palma de Mallorca, Balearic Islands · Spain

    • Albert Pérez Montaña, MD
  • ICO Badalona - Hospital Germans Trias i PujolRecruiting

    Badalona, Barcelona · Spain

    • Laura Abril Sabater, MD
    • Laura Abril Sabater, MD
  • Hospital Mutua TerrassaRecruiting

    Barcelona, Barcelona, 08221 · Spain

  • Hospital de San Juan Despí Moisès BroggiRecruiting

    Barcelona, Barcelona, 08970 · Spain

  • Hospital Clínic de BarcelonaRecruiting

    Barcelona, Barcelona · Spain

    • Carlos Fernandez de Larrea, MD
    • Carlos Fernandez de Larrea, MD
  • Hospital del MarRecruiting

    Barcelona, Barcelona · Spain

    • Eugenia Abella, MD
  • Hospital Vall d'HebronRecruiting

    Barcelona, Barcelona · Spain

    • Mercedes Gironella, MD
  • Hospital Sant Joan de Déu de ManresaRecruiting

    Manresa, Barcelona · Spain

    • Cristina Motlló, MD

Terms used on this page · explanations by MedicalUpdates.ai

relapse
A condition that improved with treatment and has since returned or worsened.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
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.
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.
principal investigator
The doctor or scientist responsible for running the study at a site or overall.
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.

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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