Waldenstrom Macroglobulinemia Clinical Trials

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Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
Contact Information
Primary
Magalie JORIS, MD
joris.magalie@chu-amiens.fr
03 22 45 54 19
Time Frame
Start Date: 2021-05-14
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
Experimental: Patients with confirmed HVS
presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
Active_comparator: Patients with confirmed absence of HVS
Experimental: Remaining patients
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Caen, Centre Henri Becquerel, Centre Hospitalier de Lens, University Hospital, Lille, Centre Hospitalier Saint Vincent
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov