Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia (SLPRaresHvisc)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Waldenstrom Macroglobulinemia; Hyperviscosity Syndrome

Treatments: Biological: blood sample; Other: fundoscopic picture; Procedure: bone marrow sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04898647

PI2020_843_0109

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Patients with confirmed HVS

Experimental group

Description:

presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity

Treatment:

Procedure: bone marrow sample

Other: fundoscopic picture

Biological: blood sample

Patients with confirmed absence of HVS

Active Comparator group

Treatment:

Procedure: bone marrow sample

Other: fundoscopic picture

Biological: blood sample

Remaining patients

Experimental group

Treatment:

Procedure: bone marrow sample

Other: fundoscopic picture

Biological: blood sample