Brief Title
Spanish Registry of Patients With IgM Monoclonal Gammopathies
Official Title
Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.
Brief 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. 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 Type
Observational
Primary Outcome
Overall survival
Condition
Waldenstrom Macroglobulinemia
Study Arms / Comparison Groups
Waldenström's macroglobulinemia cohort patient
Description: Adult patients diagnosed with Waldenström's Macroglobulinemia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
October 1, 2021
Completion Date
March 31, 2025
Primary Completion Date
March 31, 2025
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Contacts
, +34 923 291100, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT05093153
Organization ID
PRAME
Responsible Party
Sponsor
Study Sponsor
Fundación Española de Hematología y Hemoterapía
Study Sponsor
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Verification Date
November 2022