Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fundoscopic picture, blood sample, bone marrow sample.
- Who it may be relevant to
- Registry conditions: Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Correlation between items collected in questionnaires and HVS detection [Time frame: 3 years]
- Correlation between fundoscopic findings and HVS detection [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04898647 · PI2020_843_0109