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NCT Number: NCT04898647

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Daniela ROBU, MD

PRINCIPAL_INVESTIGATOR

Fabrice JARDIN, MD

PRINCIPAL_INVESTIGATOR

Gandhi DAMAJ, MD

PRINCIPAL_INVESTIGATOR

Magalie JORIS, MD

CONTACT

[email protected]

03.22.45.54.19

Stéphanie POULAIN, MD

PRINCIPAL_INVESTIGATOR

Xavier TROUSSARD, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fundoscopic picture

Other

A central review of numerised fundoscopic picture will be performed.

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

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

Primary outcomes

  1. Correlation between items collected in questionnaires and HVS detection

    Time frame: 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.

  2. Correlation between fundoscopic findings and HVS detection

    Time frame: 3 years

    Correlation between fundoscopic findings and HVS detection

Study contacts

Contact information is provided by the study sponsor or research team.

Magalie JORIS, MD

CONTACT

[email protected]

03 22 45 54 19

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Henri Becquerel
  • Centre Hospitalier Saint Vincent
  • Centre Hospitalier de Lens
  • University Hospital, Caen
  • University Hospital, Lille

Registry information

Acronym: SLPRaresHvisc

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 24, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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