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NCT Number: NCT05093153

Spanish Registry of Patients With IgM Monoclonal Gammopathies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Mérida, Mérida, Badajoz, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

ELHAM ASKARI ASKARI, MD

CONTACT

[email protected]

+34 915504800 ext. 2433

RAMON GARCIA SANZ, MD

CONTACT

[email protected]

+34 915868000 ext. 4768443

Sponsors and collaborators

Lead sponsor

Fundación Española de Hematología y Hemoterapía

Other

Registry information

Official study title

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

Acronym: PRAME

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Oct 26, 2021
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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