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.
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 type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Española de Hematología y Hemoterapía Academic / other |
| Locations | 51 sites (Mérida, Badajoz and 50 other locations) |
| Trial ID | NCT05093153 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
- Hospital de Mérida — Mérida, Badajoz, Spain (Recruiting)
- Hospital Son Llatzer — Palma, Balearic Islands, Spain (Recruiting)
- Hospital Universitario Son Espases — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
- ICO Badalona - Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)
- Hospital Mutua Terrassa — Barcelona, Barcelona, Spain (Recruiting)
- Hospital de San Juan Despí Moisès Broggi — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Barcelona, Spain (Recruiting)
- Hospital del Mar — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Vall d'Hebron — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Sant Joan de Déu de Manresa — Manresa, Barcelona, Spain (Recruiting)
- Hospital Parc Taulí — Sabadell, Barcelona, Spain (Recruiting)
- Hospital Universitario Reina Sofía — Córdoba, Córdoba, Spain (Recruiting)
- Hospital Virgen de las Nieves — Granada, Granada, Spain (Recruiting)
- Hospital Universitario Clínico San Cecilio — Granada, Granada, Spain (Recruiting)
- Hospital Juan Ramón Jiménez — Huelva, Huelva, Spain (Recruiting)
- Complejo Hospitalario Universitario de La Coruña (CHUAC) — A Coruña, La Coruña, Spain (Recruiting)
- Hospital San Pedro — Logroño, La Rioja, Spain (Recruiting)
- Hospital Universitario de Gran Canaria Dr. Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital Insular Materno Infantil- Gran Canaria — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
- CAU de León — León, León, Spain (Recruiting)
- Hospital del Bierzo — Ponferrada, León, Spain (Recruiting)
- Hospital Universitario Arnau de Vilanova — Lleida, Lleida, Spain (Recruiting)
- Hospital Universitario Gregorio Marañón — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Infanta Leonor — Madrid, Madrid, Spain (Recruiting)
- Hospital Central de La Defensa Gómez Ulla — Madrid, Madrid, Spain (Recruiting)
- Hospital Clinico Universitario Santiago de Compostela — Madrid, Madrid, Spain (Recruiting)
- Hospital de Laredo — Madrid, Madrid, Spain (Recruiting)
- Hospital Marques de Valdecilla — Madrid, Madrid, Spain (Recruiting)
- Hospital Rey Juan Carlos — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Fundación Jimenez Diaz — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (Recruiting)
- Hospital Santa Lucía de Cartagena — Cartagena, Murcia, Spain (Recruiting)
- Hospital Clinico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Recruiting)
- Hospital Costa del Sol — Marbella, Málaga, Spain (Recruiting)
- Hospital de la Serranía de Ronda — Málaga, Málaga, Spain (Recruiting)
- Hospital Regional Universitario de Málaga — Málaga, Málaga, Spain (Recruiting)
- Hospital Universitario Virgen de la Victoria — Málaga, Málaga, Spain (Recruiting)
- CUN Navarra — Pamplona, Navarre, Spain (Recruiting)
- Hospital Vital Álvarez-Buylla — Mieres, Principality of Asturias, Spain (Recruiting)
- CAU de Salamanca — Salamanca, Salamanca, Spain (Recruiting)
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital Virgen de la Macarena — Seville, Sevilla, Spain (Recruiting)
- Hospital Virgen de Valme — Seville, Sevilla, Spain (Recruiting)
- Hospital Clínico de Valencia — Valencia, Valencia, Spain (Recruiting)
- Hospital La Fe de Valencia — Valencia, Valencia, Spain (Recruiting)
- Hospital Universitario Doctor Peset — Valencia, Valencia, Spain (Recruiting)
- Hospital de Galdakao — Galdakao, Vizcaya, Spain (Recruiting)
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Zaragoza, Spain (Recruiting)
+1 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Ramon Garcia Sanz, Md
- Email: rgarcias@usal.es
- Phone: +34 915868000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.