Brief Title
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Official Title
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Brief Summary
Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic
infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical
manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in
circulating blood or to some physicochemical characteristics such as the presence of a
cryoglobulin property. Although HVS is one of the most frequent criteria for initiating
therapy in WM, few studies focused on its description and no diagnostic criteria are
available.
The present study aims to identify a diagnostic system for HVS, taking into account objective
symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue
and comorbidities that may influence the severity of symptoms.
Study Type
Interventional
Primary Outcome
Correlation between items collected in questionnaires and HVS detection
Condition
Hyperviscosity Syndrome
Intervention
fundoscopic picture
Study Arms / Comparison Groups
Patients with confirmed HVS
Description: presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
100
Start Date
May 14, 2021
Completion Date
August 2024
Primary Completion Date
May 2024
Eligibility Criteria
Inclusion Criteria:
- Patient with WM
- Patients that may require a first-line or subsequent-line therapy
- patients who will require treatment initiation
- patients with serum monoclonal component concentration greater than 15 g/L and who
will underwent hyperviscosity assessment, even if hyperviscosity is not found and in
the absence of other treatment criteria, no treatment is finally initiated.
- Patients agreeing to give informed consent.
Exclusion Criteria:
- Patients with another chronic B-cell malignancy
- patients with lymphoplasmacytic proliferations
- patients with marginal zone lymphoma.
- patients with WM and histologic transformation
- Absence of informed consent.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 03 22 45 54 19, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04898647
Organization ID
PI2020_843_0109
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier Saint Vincent
Study Sponsor
, ,
Verification Date
February 2023