Actively Recruiting

Age: 18Years +
All Genders
NCT05093153

Spanish Registry of Patients With IgM Monoclonal Gammopathies

Led by Fundación Española de Hematología y Hemoterapía · Updated on 2026-02-23

1000

Participants Needed

51

Research Sites

439 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Spanish Registry of Patients With IgM Monoclonal Gammopathies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed diagnosis in the past 30 years of Monoclonal Gammopathy of uncertain significance - IgM
  • Confirmed diagnosis in the past 30 years of asymptomatic Waldenstr�f6m's macroglobulinemia
  • Confirmed diagnosis in the past 30 years of symptomatic Waldenstr�f6m's macroglobulinemia
Not Eligible

You will not qualify if you...

  • Diagnosis of other subtypes of lymphoproliferative diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 51 locations

1

Hospital de Mérida

Mérida, Badajoz, Spain, 06800

Actively Recruiting

2

Hospital Son Llatzer

Palma, Balearic Islands, Spain

Actively Recruiting

3

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Actively Recruiting

4

ICO Badalona - Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Actively Recruiting

5

Hospital Mutua Terrassa

Barcelona, Barcelona, Spain, 08221

Actively Recruiting

6

Hospital de San Juan Despí Moisès Broggi

Barcelona, Barcelona, Spain, 08970

Actively Recruiting

7

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Actively Recruiting

8

Hospital del Mar

Barcelona, Barcelona, Spain

Actively Recruiting

9

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Actively Recruiting

10

Hospital Sant Joan de Déu de Manresa

Manresa, Barcelona, Spain

Actively Recruiting

11

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Actively Recruiting

12

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Actively Recruiting

13

Hospital Virgen de las Nieves

Granada, Granada, Spain, 18014

Actively Recruiting

14

Hospital Universitario Clínico San Cecilio

Granada, Granada, Spain

Actively Recruiting

15

Hospital Juan Ramón Jiménez

Huelva, Huelva, Spain, 21005

Actively Recruiting

16

Complejo Hospitalario Universitario de La Coruña (CHUAC)

A Coruña, La Coruña, Spain

Actively Recruiting

17

Hospital San Pedro

Logroño, La Rioja, Spain, 26006

Actively Recruiting

18

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain, 35010

Actively Recruiting

19

Hospital Insular Materno Infantil- Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain, 35016

Actively Recruiting

20

CAU de León

León, León, Spain

Actively Recruiting

21

Hospital del Bierzo

Ponferrada, León, Spain, 24404

Actively Recruiting

22

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, Spain

Actively Recruiting

23

Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain, 28007

Actively Recruiting

24

Hospital Universitario Infanta Leonor

Madrid, Madrid, Spain, 28031

Actively Recruiting

25

Hospital Central de La Defensa Gómez Ulla

Madrid, Madrid, Spain, 28040

Actively Recruiting

26

Hospital Clinico Universitario Santiago de Compostela

Madrid, Madrid, Spain, 28040

Actively Recruiting

27

Hospital de Laredo

Madrid, Madrid, Spain, 28040

Actively Recruiting

28

Hospital Marques de Valdecilla

Madrid, Madrid, Spain, 28040

Actively Recruiting

29

Hospital Rey Juan Carlos

Madrid, Madrid, Spain, 28040

Actively Recruiting

30

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain, 28041

Actively Recruiting

31

Hospital Universitario Fundación Jimenez Diaz

Madrid, Madrid, Spain

Actively Recruiting

32

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Actively Recruiting

33

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Actively Recruiting

34

Hospital Santa Lucía de Cartagena

Cartagena, Murcia, Spain, 28040

Actively Recruiting

35

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Actively Recruiting

36

Hospital Costa del Sol

Marbella, Málaga, Spain

Actively Recruiting

37

Hospital de la Serranía de Ronda

Málaga, Málaga, Spain, 29400

Actively Recruiting

38

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Actively Recruiting

39

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Actively Recruiting

40

CUN Navarra

Pamplona, Navarre, Spain

Actively Recruiting

41

Hospital Vital Álvarez-Buylla

Mieres, Principality of Asturias, Spain

Actively Recruiting

42

CAU de Salamanca

Salamanca, Salamanca, Spain

Actively Recruiting

43

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Actively Recruiting

44

Hospital Virgen de la Macarena

Seville, Sevilla, Spain, 41009

Actively Recruiting

45

Hospital Virgen de Valme

Seville, Sevilla, Spain, 41014

Actively Recruiting

46

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Actively Recruiting

47

Hospital La Fe de Valencia

Valencia, Valencia, Spain

Actively Recruiting

48

Hospital Universitario Doctor Peset

Valencia, Valencia, Spain

Actively Recruiting

49

Hospital de Galdakao

Galdakao, Vizcaya, Spain, 48960

Actively Recruiting

50

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, Spain

Actively Recruiting

51

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Actively Recruiting

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Research Team

R

RAMON GARCIA SANZ, MD

CONTACT

E

ELHAM ASKARI ASKARI, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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