Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Conditions
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Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia

Intervention / Treatment
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* Other: fundoscopic picture
* Biological: blood sample
* Procedure: bone marrow sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with confirmed HVS<br>presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity | Other: fundoscopic picture<br>* A central review of numerised fundoscopic picture will be performed.<br>Biological: blood sample<br>* 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<br>Procedure: bone marrow sample<br>* Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM<br>|
| Active Comparator: Patients with confirmed absence of HVS<br> | Other: fundoscopic picture<br>* A central review of numerised fundoscopic picture will be performed.<br>Biological: blood sample<br>* 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<br>Procedure: bone marrow sample<br>* Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM<br>|
| Experimental: Remaining patients<br> | Other: fundoscopic picture<br>* A central review of numerised fundoscopic picture will be performed.<br>Biological: blood sample<br>* 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<br>Procedure: bone marrow sample<br>* Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between items collected in questionnaires and HVS detection | 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. | 3 years | 
| Correlation between fundoscopic findings and HVS detection | Correlation between fundoscopic findings and HVS detection | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia