About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients with another chronic B-cell malignancy
patients with lymphoplasmacytic proliferations
patients with marginal zone lymphoma.
patients with WM and histologic transformation
Trial design
Treatments tested in this trial
- fundoscopic picture
- blood sample
- bone marrow sample
Treatment groups
Sponsors and collaborators
Centre Hospitalier Universitaire, Amiens
Lead sponsor
Centre Hospitalier Saint Vincent
Collaborator
Centre Henri Becquerel
Collaborator
University Hospital, Caen
Collaborator
University Hospital, Lille
Collaborator
Centre Hospitalier de Lens
Collaborator