Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia
Conditions
Keywords
Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia
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.
Interventions
OTHERfundoscopic picture
A central review of numerised fundoscopic picture will be performed.
BIOLOGICALblood 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
PROCEDUREbone 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
Sponsors
Centre Hospitalier Saint Vincent
Centre Henri Becquerel
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier de Lens
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Correlation between fundoscopic findings and HVS detection | 3 years | Correlation between fundoscopic findings and HVS detection |
Countries
France
Contacts
Primary ContactMagalie JORIS, MD
Outcome results
None listed