Spanish Registry of Patients With IgM Monoclonal Gammopathies
PRAME
1 other identifier
observational
1,000
1 country
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
February 23, 2026
February 1, 2026
8.4 years
September 28, 2021
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival evaluation from the date of diagnosis to the death of the patient due to any cause
through study completion, an average of 4 years
Study Arms (1)
Waldenström's macroglobulinemia cohort patient
Adult patients diagnosed with Waldenström's Macroglobulinemia
Eligibility Criteria
Patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance
You may qualify if:
- 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
You may not qualify if:
- Other subtypes of Lymphoproliferative diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Hospital de Mérida
Mérida, Badajoz, 06800, 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, 08221, Spain
Hospital de San Juan Despí Moisès Broggi
Barcelona, Barcelona, 08970, 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, 18014, Spain
Hospital Universitario Clínico San Cecilio
Granada, Granada, Spain
Hospital Juan Ramón Jiménez
Huelva, Huelva, 21005, Spain
Complejo Hospitalario Universitario de La Coruña (CHUAC)
A Coruña, La Coruña, Spain
Hospital San Pedro
Logroño, La Rioja, 26006, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Insular Materno Infantil- Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
CAU de León
León, León, Spain
Hospital del Bierzo
Ponferrada, León, 24404, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Lleida, Spain
Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28031, Spain
Hospital Central de La Defensa Gómez Ulla
Madrid, Madrid, 28040, Spain
Hospital Clinico Universitario Santiago de Compostela
Madrid, Madrid, 28040, Spain
Hospital de Laredo
Madrid, Madrid, 28040, Spain
Hospital Marques de Valdecilla
Madrid, Madrid, 28040, Spain
Hospital Rey Juan Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, 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, 28040, 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, 29400, 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, 41009, Spain
Hospital Virgen de Valme
Seville, Sevilla, 41014, 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, 48960, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2021
First Posted
October 26, 2021
Study Start
October 1, 2021
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share