Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Identifying diagnostic criteria for hyperviscosity syndrome in Waldenström Macroglobulinemia

Official title: Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

Run by Centre Hospitalier Universitaire, Amiens · NCT04898647 · Data updated 2026-11-12

This study is trying to create better guidelines to diagnose hyperviscosity syndrome in people with Waldenström Macroglobulinemia by looking at both their symptoms and test results.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorCentre Hospitalier Universitaire, Amiens
Academic / other
Locations1 site (Amiens)
StatusRecruiting
StartedMay 14, 2021
Main results expectedAugust 2025
Study endsAugust 2026
Registry record updatedMay 29, 2025
Trial IDNCT04898647 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with Waldenström Macroglobulinemia who may require treatment initiation due to hyperviscosity.

Probably not a fit

Patients with other chronic B-cell malignancies or those with histologic transformation of WM may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study focuses on patients with Waldenström Macroglobulinemia (WM) to develop a diagnostic system for hyperviscosity syndrome (HVS). It aims to evaluate both objective symptoms, such as bleeding and fundoscopic findings, and subjective symptoms like fatigue and comorbidities that may affect symptom severity. Patients will undergo assessments including fundoscopic pictures, blood samples, and bone marrow samples to gather comprehensive data. The study seeks to establish clearer diagnostic criteria for HVS, which is often a reason for initiating therapy in WM patients.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic criteria for hyperviscosity syndrome, enhancing treatment decisions for patients with Waldenström Macroglobulinemia.

How similar studies have gone: While there is limited research specifically on hyperviscosity syndrome in WM, the study aims to fill a gap in existing literature, suggesting a novel approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • CHU Amiens
    Amiens, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.