Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

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

100 Participants
are divided into 3 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