Spanish registry of adults with IgM monoclonal gammopathies including Waldenström macroglobulinemia

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

Observational Fundación Española de Hematología y Hemoterapía · NCT05093153

This registry collects health, disease, and treatment history from adults in Spain with IgM monoclonal gammopathies, including Waldenström macroglobulinemia, to see which treatments lead to better long-term outcomes.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorFundación Española de Hematología y Hemoterapía Academic / other
Locations51 sites (Mérida, Badajoz and 50 other locations)
Trial IDNCT05093153 on ClinicalTrials.gov

What this trial studies

This is a retrospective, observational, multicenter registry compiling data on adults diagnosed in Spain with IgM monoclonal gammopathies (MGUS‑IgM), asymptomatic Waldenström macroglobulinemia, or symptomatic Waldenström macroglobulinemia over the past 30 years. Participating hospitals will contribute clinical characteristics, diagnostic findings, treatment regimens, adverse events, and follow‑up outcomes to a central database. The project will describe patterns of care, long‑term safety and effectiveness of different therapies, and provide estimates of incidence and prognosis in the Spanish population. Data will be abstracted from medical records at participating centers and analyzed using descriptive statistics and survival/outcome comparison methods.

Who should consider this trial

Good fit: Adults (age ≥18) in Spain with a confirmed diagnosis in the past 30 years of IgM MGUS, asymptomatic Waldenström macroglobulinemia, or symptomatic Waldenström macroglobulinemia are eligible.

Not a fit: Patients with other subtypes of lymphoproliferative disease or those seeking immediate access to experimental therapies are unlikely to receive direct treatment benefit from this retrospective registry.

Why it matters

Potential benefit: If successful, the registry could help clinicians choose treatments that offer better long‑term outcomes and inform national care guidelines for WM in Spain.

How similar studies have performed: Similar national and international registries for WM and IgM MGUS have provided useful epidemiologic and outcomes information, although WM remains rare and data are still limited.

Eligibility criteria

Show full inclusion / exclusion criteria
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.

Where this trial is running

Mérida, Badajoz and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Waldenstrom Macroglobulinemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.