Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Not Applicable

Recruiting

• Conditions: Waldenstrom Macroglobulinemia; Hyperviscosity Syndrome
• Interventions: Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample

• Registration Number: NCT04898647
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-14
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remaining patients	fundoscopic picture	-
Patients with confirmed HVS	bone marrow sample	presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
Patients with confirmed absence of HVS	fundoscopic picture	-
Patients with confirmed absence of HVS	bone marrow sample	-
Patients with confirmed HVS	fundoscopic picture	presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
Patients with confirmed HVS	blood sample	presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
Patients with confirmed absence of HVS	blood sample	-
Remaining patients	bone marrow sample	-
Remaining patients	blood sample	-

Primary Outcome Measures

Name	Time	Method
Correlation between fundoscopic findings and HVS detection	3 years	Correlation between fundoscopic findings and HVS detection
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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France