Clinical trial

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Name

PI2020_843_0109

Description

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.

Trial arms

Trial start

2021-05-14

Estimated PCD

2024-05-01

Trial end

2024-08-01

Status

Recruiting

Treatment

fundoscopic picture

A central review of numerised fundoscopic picture will be performed.

Arms:

Patients with confirmed HVS, Patients with confirmed absence of HVS, Remaining patients

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

Arms:

Patients with confirmed HVS, Patients with confirmed absence of HVS, Remaining patients

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

Arms:

Patients with confirmed HVS, Patients with confirmed absence of HVS, Remaining patients

Size

100

Primary endpoint

Correlation between items collected in questionnaires and HVS detection

3 years

Correlation between fundoscopic findings and HVS detection

3 years

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-02-10

1 organization

1 product

2 indications

Organization

Centre Hospitalier Universitaire Amiens

Product

Blood Sample

Indication

Hyperviscosity Syndrome

Indication

Waldenstrom Macroglobulinemia