Health TrialsbyHealthPanel

Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

ConditionsHyperviscosity SyndromeWaldenstrom Macroglobulinemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with another chronic B-cell malignancy

patients with lymphoplasmacytic proliferations

patients with marginal zone lymphoma.

patients with WM and histologic transformation

Trial design

Design model

Parallel

Treatments tested in this trial

  • fundoscopic picture

    Other intervention

    A central review of numerised fundoscopic picture will be performed.

  • blood sample

    Biological/Vaccine

    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/Surgery

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

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Patients with confirmed HVSExperimental treatment 3 interventions
Group B: Patients with confirmed absence of HVSActive comparator 3 interventions
Group C: Remaining patientsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years
2

Correlation between fundoscopic findings and HVS detection

Correlation between fundoscopic findings and HVS detection

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Centre Hospitalier Saint Vincent

Collaborator

Centre Henri Becquerel

Collaborator

University Hospital, Caen

Collaborator

University Hospital, Lille

Collaborator

Centre Hospitalier de Lens

Collaborator

Source ClinicalTrials.gov
Apply now