Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Last updated: May 23, 2025
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Waldenstrom Macroglobulinemia

Lymphoproliferative Disorders

Treatment

fundoscopic picture

blood sample

bone marrow sample

Clinical Study ID

NCT04898647
PI2020_843_0109
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 whowill underwent hyperviscosity assessment, even if hyperviscosity is not found and inthe absence of other treatment criteria, no treatment is finally initiated.

  • Patients agreeing to give informed consent.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: fundoscopic picture
Phase:
Study Start date:
May 14, 2021
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • CHU Amiens

    Amiens, 80480
    France

    Active - Recruiting

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