Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

NCT04898647 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire, Amiens

Phase

Not applicable

Started

2021-05-14

Last updated

2025-05-29

Condition(s) studied

Hyperviscosity SyndromeWaldenstrom Macroglobulinemia

Investigational drug(s) / intervention(s)

fundoscopic pictureblood sample →bone marrow sample

fundoscopic picture: A central review of numerised fundoscopic picture will be performed.

blood sample: Two 10 ml blood vials will be sampled in addition to standard blood sampling for getting 6 to 7 200 μL aliquot. One 5 ml EDTA vial for GP1bα expression study, only if this sample can be sent to hemostasis laboratory within the 4 hours after sampling

bone marrow sample: Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Correlation between items collected in questionnaires and HVS detection — 3 years
Correlation between items collected in questionnaires and HVS detection. Questionnaires are An oncogeriatric form for geriatric assessment, a comorbidity assessment form, a fatigue and quality of live assessment form, and an hemorrhagic assessment form.
Correlation between fundoscopic findings and HVS detection — 3 years
Correlation between fundoscopic findings and HVS detection

Trial sites (1)

Facility	City	Region	Status
CHU Amiens	Amiens	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04898647 on ClinicalTrials.gov ↗ ← All trials in France