Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

NCT04898647 | Recruiting

• 1 other identifier: PI2020_843_0109
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperviscosity Syndrome; Waldenstrom Macroglobulinemia

Keywords

Hyperviscosity Syndrome; Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Patients with confirmed HVS

EXPERIMENTAL

presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity

Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample

Patients with confirmed absence of HVS

ACTIVE COMPARATOR

Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample

Remaining patients

EXPERIMENTAL

Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample

Interventions

fundoscopic picture OTHER

A central review of numerised fundoscopic picture will be performed.

Patients with confirmed HVS; Patients with confirmed absence of HVS; Remaining patients

blood sample BIOLOGICAL

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

Patients with confirmed HVS; Patients with confirmed absence of HVS; Remaining patients

bone marrow sample PROCEDURE

Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM

Patients with confirmed HVS; Patients with confirmed absence of HVS; Remaining patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier Saint Vincent: collaborator
• Centre Henri Becquerel: collaborator
• University Hospital, Caen: collaborator
• University Hospital, Lille: collaborator
• Centre Hospitalier de Lens: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Magalie JORIS, MD

CONTACT

03 22 45 54 19; joris.magalie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 24, 2021
• Study Start: May 14, 2021
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)