Spanish Registry of Patients With IgM Monoclonal Gammopathies (PRAME)

February 19, 2026 updated by: Fundación Española de Hematología y Hemoterapía

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: RAMON GARCIA SANZ, MD
  • Phone Number: 4768443 +34 915868000
  • Email: rgarcias@usal.es

Study Contact Backup

  • Name: ELHAM ASKARI ASKARI, MD
  • Phone Number: 2433 +34 915504800
  • Email: easkari@fdj.es

Study Locations

  • Spain
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • Recruiting
        • Hospital de Mérida
        • Contact:
          • ELENA PAUMARD RODRIGUEZ, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • ELENA PAUMARD RODRIGUEZ, MD
    • Balearic Islands
      • Palma, Balearic Islands, Spain
        • Recruiting
        • Hospital Son Llatzer
        • Contact:
          • Joan Bargay, MD
      • Palma de Mallorca, Balearic Islands, Spain
        • Recruiting
        • Hospital Universitario Son Espases
        • Contact:
          • Albert Pérez Montaña, MD
    • Barcelona
      • Badalona, Barcelona, Spain
        • Recruiting
        • ICO Badalona - Hospital Germans Trias I Pujol
        • Contact:
          • Laura Abril Sabater, MD
        • Principal Investigator:
          • Laura Abril Sabater, MD
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Hospital Del Mar
        • Contact:
          • Eugenia Abella, MD
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Hospital Vall d'hebrón
        • Contact:
          • Mercedes Gironella, MD
      • Barcelona, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Mutua Terrassa
        • Contact:
          • Carles Tolosa Ridao, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Carles Tolosa Ridao, MD
      • Barcelona, Barcelona, Spain, 08970
        • Recruiting
        • Hospital de San Juan Despí Moisès Broggi
        • Contact:
          • Elena Cabezudo, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Elena Cabezudo, MD
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Carlos Fernandez de Larrea, MD
        • Principal Investigator:
          • Carlos Fernandez de Larrea, MD
      • Manresa, Barcelona, Spain
        • Recruiting
        • Hospital Sant Joan de Deu de Manresa
        • Contact:
          • Cristina Motlló, MD
      • Sabadell, Barcelona, Spain
        • Recruiting
        • Hospital Parc Tauli
        • Contact:
          • Cristina Motlló, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Cristina Motlló, MD
    • Córdoba
      • Córdoba, Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Miguel Ángel Álvarez, MD
    • Granada
      • Granada, Granada, Spain, 18014
        • Recruiting
        • Hospital Virgen de las Nieves
        • Contact:
          • Amanda Núñez García, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Amanda Núñez García, MD
      • Granada, Granada, Spain
        • Recruiting
        • Hospital Universitario Clínico San Cecilio
        • Contact:
          • Isabel García Cabrera, MD
    • Huelva
      • Huelva, Huelva, Spain, 21005
        • Recruiting
        • Hospital Juan Ramón Jiménez
        • Contact:
          • Sofía Vázquez Díaz, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Sofía Vázquez Díaz, MD
    • La Coruña
      • A Coruña, La Coruña, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de La Coruña (CHUAC)
        • Contact:
          • Ana Vale López, MD
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Recruiting
        • Hospital San Pedro
        • Contact:
          • María José Najera Irazu, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • María José Najera Irazu, MD
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr. Negrín
        • Contact:
          • Alexia Suárez Cabrera, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Alexia Suárez Cabrera, MD
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Insular Materno Infantil- Gran Canaria
        • Contact:
          • CRISTINA LEMES QUINTANA, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • CRISTINA LEMES QUINTANA, MD
    • León
      • León, León, Spain
        • Recruiting
        • CAU de León
        • Contact:
          • Fernando Escalante, MD
        • Principal Investigator:
          • Fernando Escalante, MD
      • Ponferrada, León, Spain, 24404
        • Recruiting
        • Hospital del Bierzo
        • Contact:
          • Carmen Aguilera, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Carmen Aguilera, MD
    • Lleida
      • Lleida, Lleida, Spain
        • Recruiting
        • Hospital Universitario Arnau de Vilanova
        • Contact:
          • Antonio GARCIA GUIÑON, MD
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Fatima Miras Calvo, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Fatima Miras Calvo, MD
      • Madrid, Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Mª Angeles Foncillas García, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Mª Angeles Foncillas García, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:
          • Elham Askari, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Elham Askari, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • María Jesús Blanchard, MD
      • Madrid, Madrid, Spain, 28007
        • Recruiting
        • Hospital Universitario Gregorio Marañón
        • Contact:
          • Ramón García Sanz, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Ramón García Sanz, MD
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Central de la Defensa Gómez Ulla
        • Contact:
          • Mª Teresa Calderón López, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Mª Teresa Calderón López, MD
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico Universitario Santiago de Compostela
        • Contact:
          • Marta Sonia Gonzalez, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Marta Sonia Gonzalez, MD
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital de Laredo
        • Contact:
          • Diana Sánchez Argüello, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Diana Sánchez Argüello, MD
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Marqués de Valdecilla
        • Contact:
          • Arancha Bermúdez, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Arancha Bermúdez, MD
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Rey Juan Carlos
        • Contact:
          • Carolina Miranda Castillo, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Carolina Miranda Castillo, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta De Hierro
        • Contact:
          • María Belén Navarro Matilla, MD
    • Murcia
      • Cartagena, Murcia, Spain, 28040
        • Recruiting
        • Hospital Santa Lucía de Cartagena
        • Contact:
          • Marta Romera, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Marta Romera, MD
      • El Palmar, Murcia, Spain
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
        • Contact:
          • Angela Heredia Cano, MD
    • Málaga
      • Marbella, Málaga, Spain
        • Recruiting
        • Hospital Costa del Sol
        • Contact:
          • Maria CASANOVA ESPINOSA, MD
      • Málaga, Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Contact:
          • María Alcalá Peña, MD
      • Málaga, Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Ricarda García Sánchez, MD
      • Málaga, Málaga, Spain, 29400
        • Recruiting
        • Hospital de la Serranía de Ronda
        • Contact:
          • Reyes Jiménez Bárcenas, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Reyes Jiménez Bárcenas, MD
    • Navarre
      • Pamplona, Navarre, Spain
        • Recruiting
        • CUN Navarra
        • Contact:
          • Miguel Angel Canales Albendea, MD
    • Principality of Asturias
      • Mieres, Principality of Asturias, Spain
        • Recruiting
        • Hospital Vital Álvarez-Buylla
        • Contact:
          • Francisco Taboada, MD
    • Salamanca
      • Salamanca, Salamanca, Spain
        • Recruiting
        • CAU de Salamanca
        • Contact:
          • Cristina de Ramón, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Cristina de Ramón, MD
    • Santa Cruz de Tenerife
      • Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
        • Recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contact:
          • Pablo Rios Rull, MD
    • Sevilla
      • Seville, Sevilla, Spain, 41009
        • Recruiting
        • Hospital Virgen de la Macarena
        • Contact:
          • Rafael Duro Millán, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Rafael Duro Millán, MD
      • Seville, Sevilla, Spain, 41014
        • Recruiting
        • Hospital Virgen de Valme
        • Contact:
          • Virgilio Calama, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Virgilio Calama, MD
    • Valencia
      • Valencia, Valencia, Spain
        • Recruiting
        • Hospital Universitario Doctor Peset
        • Contact:
          • Paz Rivas, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
        • Principal Investigator:
          • Paz Rivas, MD
      • Valencia, Valencia, Spain
        • Recruiting
        • Hospital Clínico de Valencia
        • Principal Investigator:
          • Ana Saus Carreres, MD
        • Contact:
          • Ana Saus Carreres, MD
          • Phone Number: +34 913191998
          • Email: sehh@sehh.es
      • Valencia, Valencia, Spain
        • Recruiting
        • Hospital La Fe de Valencia
        • Contact:
          • Mario Arnao Herráiz, MD
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Recruiting
        • Hospital de Galdakao
        • Contact:
          • Garazi Letamendi, MD
    • Zaragoza
      • Zaragoza, Zaragoza, Spain
        • Recruiting
        • Hospital Clínico Universitario Lozano Blesa
        • Contact:
          • Victoria Dourdil Sahun, MD
      • Zaragoza, Zaragoza, Spain
        • Recruiting
        • Hospital Miguel Servet
        • Contact:
          • Ana Godoy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Waldenström's macroglobulinemia cohort patient
Adult patients diagnosed with Waldenström's Macroglobulinemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: through study completion, an average of 4 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Española de Hematología y Hemoterapía

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRAME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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