Clinical trial NCT05093153: Spanish Registry of Patients With IgM Monoclonal Gammopathies
Official title: Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Waldenstrom Macroglobulinemia
Lead sponsor: Fundación Española de Hematología y Hemoterapía
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance

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.


Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mieres
country: Spain
facility: Hospital Vital Álvarez-Buylla
state: Asturias
city: Badalona
country: Spain
facility: ICO Badalona - Hospital Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Hospital Sant Joan de Déu de Manresa
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
state: Cantabria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Palma
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: La Coruña
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
state: Murcia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: CUN Navarra
state: Navarra
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario de La Coruña (CHUAC)
city: León
country: Spain
facility: CAU de León
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: CAU de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
References: