Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia (SLPRaresHvisc)

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.

Study Overview

• Status: Recruiting
• Conditions: Waldenstrom Macroglobulinemia; Hyperviscosity Syndrome
• Intervention / Treatment: Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magalie JORIS, MD; Phone Number: 03 22 45 54 19; Email: joris.magalie@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Contact: Magalie JORIS, MD; Phone Number: 03.22.45.54.19; Email: joris.magalie@chu-amiens.fr
    • Principal Investigator: Xavier TROUSSARD, MD
    • Principal Investigator: Stéphanie POULAIN, MD
    • Principal Investigator: Daniela ROBU, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with confirmed HVS; presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity	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 GP1bα 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
ACTIVE_COMPARATOR: Patients with confirmed absence of HVS	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 GP1bα 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
EXPERIMENTAL: Remaining patients	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 GP1bα 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Henri Becquerel; University Hospital, Caen; University Hospital, Lille; Centre Hospitalier de Lens; Centre Hospitalier Saint Vincent

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 14, 2021
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (ACTUAL): May 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Waldenstrom Macroglobulinemia; Hyperviscosity Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Syndrome; Waldenstrom Macroglobulinemia
• Other Study ID Numbers: PI2020_843_0109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No