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RECRUITING
NCT05093153

Spanish Registry of Patients With IgM Monoclonal Gammopathies

Sponsor: Fundación Española de Hematología y Hemoterapía

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2021-10-01

Completion Date

2030-03

Last Updated

2026-02-23

Healthy Volunteers

No

Locations (51)

Hospital de Mérida

Mérida, Badajoz, Spain

Hospital Son Llatzer

Palma, Balearic Islands, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

ICO Badalona - Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Mutua Terrassa

Barcelona, Barcelona, Spain

Hospital de San Juan Despí Moisès Broggi

Barcelona, Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Sant Joan de Déu de Manresa

Manresa, Barcelona, Spain

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Virgen de las Nieves

Granada, Granada, Spain

Hospital Universitario Clínico San Cecilio

Granada, Granada, Spain

Hospital Juan Ramón Jiménez

Huelva, Huelva, Spain

Complejo Hospitalario Universitario de La Coruña (CHUAC)

A Coruña, La Coruña, Spain

Hospital San Pedro

Logroño, La Rioja, Spain

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Insular Materno Infantil- Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

CAU de León

León, León, Spain

Hospital del Bierzo

Ponferrada, León, Spain

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, Spain

Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Spain

Hospital Central de La Defensa Gómez Ulla

Madrid, Madrid, Spain

Hospital Clinico Universitario Santiago de Compostela

Madrid, Madrid, Spain

Hospital de Laredo

Madrid, Madrid, Spain

Hospital Marques de Valdecilla

Madrid, Madrid, Spain

Hospital Rey Juan Carlos

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Fundación Jimenez Diaz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Santa Lucía de Cartagena

Cartagena, Murcia, Spain

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Costa del Sol

Marbella, Málaga, Spain

Hospital de la Serranía de Ronda

Málaga, Málaga, Spain

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

CUN Navarra

Pamplona, Navarre, Spain

Hospital Vital Álvarez-Buylla

Mieres, Principality of Asturias, Spain

CAU de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Hospital Virgen de la Macarena

Seville, Sevilla, Spain

Hospital Virgen de Valme

Seville, Sevilla, Spain

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Hospital La Fe de Valencia

Valencia, Valencia, Spain

Hospital Universitario Doctor Peset

Valencia, Valencia, Spain

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, Spain

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain