Spanish Registry of Patients With IgM Monoclonal Gammopathies

Waldenstrom Macroglobulinemia Clinical Trial

— PRAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05093153
• Other study ID #: PRAME
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2022
• Source: Fundación Española de Hematología y Hemoterapía
• Contact: RAMON GARCIA SANZ, MD
• Phone: +34 923 291100
• Email: rgarcias[@]usal.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Locations

Country	Name	City	State
Spain	ICO Badalona - Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Clinico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital de Galdakao	Galdakao	Vizcaya
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Complejo Hospitalario Universitario de La Coruña (CHUAC)	La Coruña
Spain	CAU de León	León
Spain	Hospital Universitario Arnau de Vilanova	Lleida
Spain	Hospital Universitario Fundación Jimenez Diaz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Sant Joan de Déu de Manresa	Manresa	Barcelona
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Vital Álvarez-Buylla	Mieres	Asturias
Spain	Hospital Son Llatzer	Palma	Islas Baleares
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	CUN Navarra	Pamplona	Navarra
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	CAU de Salamanca	Salamanca
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife
Spain	Hospital Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela	La Coruña
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital La Fe de Valencia	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Española de Hematología y Hemoterapía

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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