AzTrials
AzTrials

Waldenstrom MacroglobulinemiaPRAMENCT05093153

Spanish Registry of Patients With IgM Monoclonal Gammopathies

An observational study of Waldenstrom Macroglobulinemia, run by Fundación Española de Hematología y Hemoterapía at 51 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Waldenstrom Macroglobulinemia
How many people
1,000 participants
Where
51 sitesSpain
Study dates
1 Oct 2021to Mar 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Other subtypes of Lymphoproliferative diseases.

Trial locations and contacts

51 sites in 1 country. Contact the study team or a site near you to ask about taking part.

RAMON GARCIA SANZ, MD contact

+34 915868000 ext. 4768443

rgarcias@usal.es

ELHAM ASKARI ASKARI, MD contact

+34 915504800 ext. 2433

easkari@fdj.es

51 sites in 1 country

Spain51 sites, 51 recruiting
  • Complejo Hospitalario Universitario de La Coruña (CHUAC)

    A Coruña, La Coruña

    Ana Vale López, MD

    Recruiting
  • ICO Badalona - Hospital Germans Trias i Pujol

    Badalona, Barcelona

    Laura Abril Sabater, MD

    Laura Abril Sabater, MD

    Recruiting
  • Hospital Mutua Terrassa

    Barcelona, Barcelona, 08221

    Carles Tolosa Ridao, MD, +34 913191998, sehh@sehh.es

    Carles Tolosa Ridao, MD

    Recruiting
  • Hospital de San Juan Despí Moisès Broggi

    Barcelona, Barcelona, 08970

    Elena Cabezudo, MD, +34 913191998, sehh@sehh.es

    Elena Cabezudo, MD

    Recruiting
  • Hospital Clínic de Barcelona

    Barcelona, Barcelona

    Carlos Fernandez de Larrea, MD

    Carlos Fernandez de Larrea, MD

    Recruiting
  • Hospital del Mar

    Barcelona, Barcelona

    Eugenia Abella, MD

    Recruiting
  • Hospital Vall d'Hebron

    Barcelona, Barcelona

    Mercedes Gironella, MD

    Recruiting
  • Hospital Santa Lucía de Cartagena

    Cartagena, Murcia, 28040

    Marta Romera, MD, +34 913191998, sehh@sehh.es

    Marta Romera, MD

    Recruiting
  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba

    Miguel Ángel Álvarez, MD

    Recruiting
  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia

    Angela Heredia Cano, MD

    Recruiting
  • Hospital de Galdakao

    Galdakao, Vizcaya, 48960

    Garazi Letamendi, MD

    Recruiting
  • Hospital Virgen de las Nieves

    Granada, Granada, 18014

    Amanda Núñez García, MD, +34 913191998, sehh@sehh.es

    Amanda Núñez García, MD

    Recruiting
  • Hospital Universitario Clínico San Cecilio

    Granada, Granada

    Isabel García Cabrera, MD

    Recruiting
  • Hospital Juan Ramón Jiménez

    Huelva, Huelva, 21005

    Sofía Vázquez Díaz, MD, +34 913191998, sehh@sehh.es

    Sofía Vázquez Díaz, MD

    Recruiting
  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

    Alexia Suárez Cabrera, MD, +34 913191998, sehh@sehh.es

    Alexia Suárez Cabrera, MD

    Recruiting
  • Hospital Insular Materno Infantil- Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016

    CRISTINA LEMES QUINTANA, MD, +34 913191998, sehh@sehh.es

    CRISTINA LEMES QUINTANA, MD

    Recruiting
  • CAU de León

    León, León

    Fernando Escalante, MD

    Fernando Escalante, MD

    Recruiting
  • Hospital Universitario Arnau de Vilanova

    Lleida, Lleida

    Antonio García Guiñón, MD

    Recruiting
  • Hospital San Pedro

    Logroño, La Rioja, 26006

    María José Najera Irazu, MD, +34 913191998, sehh@sehh.es

    María José Najera Irazu, MD

    Recruiting
  • Hospital Universitario Gregorio Marañón

    Madrid, Madrid, 28007

    Ramón García Sanz, MD, +34 913191998, sehh@sehh.es

    Ramón García Sanz, MD

    Recruiting
  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28031

    Mª Angeles Foncillas García, MD, +34 913191998, sehh@sehh.es

    Mª Angeles Foncillas García, MD

    Recruiting
  • Hospital Central de La Defensa Gómez Ulla

    Madrid, Madrid, 28040

    Mª Teresa Calderón López, MD, +34 913191998, sehh@sehh.es

    Mª Teresa Calderón López, MD

    Recruiting
  • Hospital Clinico Universitario Santiago de Compostela

    Madrid, Madrid, 28040

    Marta Sonia Gonzalez, MD, +34 913191998, sehh@sehh.es

    Marta Sonia Gonzalez, MD

    Recruiting
  • Hospital de Laredo

    Madrid, Madrid, 28040

    Diana Sánchez Argüello, MD, +34 913191998, sehh@sehh.es

    Diana Sánchez Argüello, MD

    Recruiting
  • Hospital Marques de Valdecilla

    Madrid, Madrid, 28040

    Arancha Bermúdez, MD, +34 913191998, sehh@sehh.es

    Arancha Bermúdez, MD

    Recruiting
  • Hospital Rey Juan Carlos

    Madrid, Madrid, 28040

    Carolina Miranda Castillo, MD, +34 913191998, sehh@sehh.es

    Carolina Miranda Castillo, MD

    Recruiting
  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Fatima Miras Calvo, MD, +34 913191998, sehh@sehh.es

    Fatima Miras Calvo, MD

    Recruiting
  • Hospital Universitario Fundación Jimenez Diaz

    Madrid, Madrid

    Elham Askari, MD, +34 913191998, sehh@sehh.es

    Elham Askari, MD

    Recruiting
  • Hospital Universitario Puerta de Hierro

    Madrid, Madrid

    María Belén Navarro Matilla, MD

    Recruiting
  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid

    María Jesús Blanchard, MD

    Recruiting
  • Hospital de la Serranía de Ronda

    Málaga, Málaga, 29400

    Reyes Jiménez Bárcenas, MD, +34 913191998, sehh@sehh.es

    Reyes Jiménez Bárcenas, MD

    Recruiting
  • Hospital Regional Universitario de Málaga

    Málaga, Málaga

    María Alcalá Peña, MD

    Recruiting
  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga

    Ricarda García Sánchez, MD

    Recruiting
  • Hospital Sant Joan de Déu de Manresa

    Manresa, Barcelona

    Cristina Motlló, MD

    Recruiting
  • Hospital Costa del Sol

    Marbella, Málaga

    María Casanova Espinosa, MD

    Recruiting
  • Hospital de Mérida

    Mérida, Badajoz, 06800

    ELENA PAUMARD RODRIGUEZ, MD, +34 913191998, sehh@sehh.es

    ELENA PAUMARD RODRIGUEZ, MD

    Recruiting
  • Hospital Vital Álvarez-Buylla

    Mieres, Principality of Asturias

    Francisco Taboada, MD

    Recruiting
  • Hospital Son Llatzer

    Palma, Balearic Islands

    Joan Bargay, MD

    Recruiting
  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands

    Albert Pérez Montaña, MD

    Recruiting
  • CUN Navarra

    Pamplona, Navarre

    Miguel Angel Canales Albendea, MD

    Recruiting
  • Hospital del Bierzo

    Ponferrada, León, 24404

    Carmen Aguilera, MD, +34 913191998, sehh@sehh.es

    Carmen Aguilera, MD

    Recruiting
  • Hospital Parc Taulí

    Sabadell, Barcelona

    Cristina Motlló, MD, +34 913191998, sehh@sehh.es

    Cristina Motlló, MD

    Recruiting
  • CAU de Salamanca

    Salamanca, Salamanca

    Cristina de Ramón, MD, +34 913191998, sehh@sehh.es

    Cristina de Ramón, MD

    Recruiting
  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Santa Cruz de Tenerife

    Pablo Rios Rull, MD

    Recruiting
  • Hospital Virgen de la Macarena

    Seville, Sevilla, 41009

    Rafael Duro Millán, MD, +34 913191998, sehh@sehh.es

    Rafael Duro Millán, MD

    Recruiting
  • Hospital Virgen de Valme

    Seville, Sevilla, 41014

    Virgilio Calama, MD, +34 913191998, sehh@sehh.es

    Virgilio Calama, MD

    Recruiting
  • Hospital Clínico de Valencia

    Valencia, Valencia

    Ana Saus Carreres, MD, +34 913191998, sehh@sehh.es

    Ana Saus Carreres, MD

    Recruiting
  • Hospital La Fe de Valencia

    Valencia, Valencia

    Mario Arnao Herráiz, MD

    Recruiting
  • Hospital Universitario Doctor Peset

    Valencia, Valencia

    Paz Rivas, MD, +34 913191998, sehh@sehh.es

    Paz Rivas, MD

    Recruiting
  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Zaragoza

    Victoria Dourdil Sahun, MD

    Recruiting
  • Hospital Miguel Servet

    Zaragoza, Zaragoza

    Ana Godoy, MD

    Recruiting

Other trials in Spain

About this study

Official title: 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:

Read more
  • 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.

Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05093153
Study groupRoleWhat they receive
Waldenström's macroglobulinemia cohort patientAdult patients diagnosed with Waldenström's Macroglobulinemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival evaluation from the date of diagnosis to the death of the patient due to any cause

    Measured: through study completion, an average of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start1 Oct 2021
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093153
Sponsor's protocol ID
PRAME
Acronym
PRAME
Status last verified
Feb 2026
First submitted
28 Sep 2021
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Waldenstrom Macroglobulinemia, run by Fundación Española de Hematología y Hemoterapía at 51 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact RAMON GARCIA SANZ, MD (+34 915868000 ext. 4768443, rgarcias@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in