Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma

Last updated: May 20, 2025
Sponsor: Intergroupe Francophone du Myelome
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Lymphoproliferative Disorders

Multiple Myeloma

Treatment

Detection of monoclonal component

Clinical Study ID

NCT05208086
IFM 2020-03
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to evaluate at Day 1 Cycle 2, the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in patients with Multiple Myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with Multiple Myeloma

  • Patient starting new treatment line, whatever the line is, but with at least 3induction cycles

  • Urine monoclonal component ≥ 200mg/24h

Exclusion

Exclusion Criteria:

Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Detection of monoclonal component
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
May 31, 2027

Study Description

To evaluate the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in Multiple Myeloma patients.

300 evaluable patients are required. For each of them, both spot urine sample and 24h urine sample will be collected at Cycle1 Day1, Cycle 2 Day 1 and Cycle 4 Day 1.

The detection of urine monoclonal component will be performed by urine protein electrophoresis (quantitative) and urine immunofixation (qualitative).

Connect with a study center

  • Ch Annecy Genevois

    Annecy,
    France

    Active - Recruiting

  • Centre Hospitalier William Morey

    Chalon Sur Saone,
    France

    Site Not Available

  • Centre Hospitalier Métropole de Savoie

    Chambéry,
    France

    Active - Recruiting

  • CHU François Mitterand

    Dijon,
    France

    Active - Recruiting

  • CH de Dunkerque

    Dunkerque,
    France

    Active - Recruiting

  • CHD Vendée

    La Roche Sur Yon,
    France

    Active - Recruiting

  • Hopital Bicètre

    Le Kremlin Bicètre,
    France

    Active - Recruiting

  • Ch Le Mans

    Le Mans,
    France

    Active - Recruiting

  • CH de Lens

    Lens,
    France

    Active - Recruiting

  • Hopital Claude Huriez-CHRU LILLE

    Lille,
    France

    Active - Recruiting

  • Centre Hospitalier Lyon sud

    Lyon,
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU saint Eloi

    Montpellier,
    France

    Site Not Available

  • Hôpital E. MULLER

    Mulhouse,
    France

    Active - Recruiting

  • CHRU Nantes

    Nantes,
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU de Reims

    Reims,
    France

    Site Not Available

  • Chu Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • CHRU Bretonneau

    Tours,
    France

    Active - Recruiting

  • CH Bretagne Atlantique Vannes et Auray-P.Chubert

    Vannes,
    France

    Active - Recruiting

  • CH de Versailles

    Versailles,
    France

    Active - Recruiting

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