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Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Universitaire, Amiens
NCT04898647 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • fundoscopic picture
  • blood sample
  • bone marrow sample
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Where

1 site
CHU Amiens
Amiens, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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