NCT04898647

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperviscosity Syndrome
• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
OTHER	fundoscopic picture	A central review of numerised fundoscopic picture will be performed.
BIOLOGICAL	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
PROCEDURE	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

Timeline

• Start date: 2021-05-14
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2021-05-24
• Last updated: 2025-05-29

Locations

1 site across 1 country: France