Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Waldenstrom Macroglobulinemia Clinical Trial

— SLPRaresHvisc  

Official title:

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898647
• Other study ID #: PI2020_843_0109
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: August 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Magalie JORIS, MD
• Phone: 03 22 45 54 19
• Email: joris.magalie[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperviscosity Syndrome
• Syndrome
• Waldenstrom Macroglobulinemia

Intervention

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 GP1ba 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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Henri Becquerel, Centre Hospitalier de Lens, Centre Hospitalier Saint Vincent, University Hospital, Caen, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Correlation between fundoscopic findings and HVS detection	Correlation between fundoscopic findings and HVS detection	3 years