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.
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.
51 sites in 1 country
Spain51 sites, 51 recruiting
- 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
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.
- Conditions
- Waldenstrom Macroglobulinemia
- 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 group | Role | What they receive |
|---|---|---|
| Waldenström's macroglobulinemia cohort patient | Adult patients diagnosed with Waldenström's Macroglobulinemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted26 Oct 2021
- Study start1 Oct 2021
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom MacroglobulinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundación Española de Hematología y Hemoterapía
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.
- ClinicalTrials.gov ID
- NCT05093153
- Acronym / sponsor ID
- PRAME / PRAME
- Conditions
- Waldenstrom Macroglobulinemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundación Española de Hematología y HemoterapíaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Waldenström's macroglobulinemia cohort patient | – | –Adult patients diagnosed with Waldenström's Macroglobulinemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Other subtypes of Lymphoproliferative diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Waldenstrom Macroglobulinemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Not yet recruitingPhase 2
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
Waldenstrom Macroglobulinemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
51 sites in 1 country: see every site and its status.
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.