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

Primary Purpose

Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

fundoscopic picture

blood sample

bone marrow sample

About this trial

This is an interventional diagnostic trial for Hyperviscosity Syndrome focused on measuring Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Patients with confirmed HVS

Patients with confirmed absence of HVS

Remaining patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Correlation between fundoscopic findings and HVS detection

Secondary Outcome Measures

Full Information

NCT ID

NCT04898647

First Posted

May 17, 2021

Last Updated

February 9, 2023

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04898647

Brief Title

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Acronym

SLPRaresHvisc

Official Title

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 14, 2021 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia

Keywords

Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with confirmed HVS

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with confirmed absence of HVS

Arm Type

Active Comparator

Arm Title

Remaining patients

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

fundoscopic picture

Intervention Description

A central review of numerised fundoscopic picture will be performed.

Intervention Type

Biological

Intervention Name(s)

blood sample

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

bone marrow sample

Intervention Description

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

Primary Outcome Measure Information:

Title

Correlation between items collected in questionnaires and HVS detection

Description

Time Frame

3 years

Title

Correlation between fundoscopic findings and HVS detection

Description

Correlation between fundoscopic findings and HVS detection

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Magalie JORIS, MD

Phone

03 22 45 54 19

joris.magalie@chu-amiens.fr

Facility Information:

Facility Name

CHU Amiens

City

Amiens

ZIP/Postal Code

80480

Country

France

Individual Site Status

Recruiting

Facility Contact: