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

April 8, 2026 updated by: Intergroupe Francophone du Myelome

Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma RHU(M)M Random or H24 Urine in (Multiple) Myeloma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

180 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).

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • Ch Annecy Genevois
      • Chambéry, France
        • Centre Hospitalier Métropole de Savoie
      • Dijon, France
        • Chu Francois Mitterand
      • Dunkirk, France
        • CH de Dunkerque
      • La Roche-sur-Yon, France
        • CHD Vendee
      • Le Kremlin Bicètre, France
        • Hôpital Bicêtre
      • Le Mans, France
        • CH Le mans
      • Lens, France
        • CH de Lens
      • Lille, France
        • Hopital Claude Huriez-CHRU LILLE
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Montpellier, France
        • CHU de Montpellier
      • Mulhouse, France
        • Hôpital E. Muller
      • Nantes, France
        • CHRU Nantes
      • Rennes, France
        • Chu Pontchaillou
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • CHRU Bretonneau
      • Vannes, France
        • CH Bretagne Atlantique Vannes et Auray-P.Chubert
      • Versailles, France
        • CH de Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Multiple Myeloma whatever the line of treatment started in one of the twenty investigators sites located in France.

Description

Inclusion Criteria:

  • Patient with Multiple Myeloma
  • Patient starting new treatment line, whatever the line is, but with at least 3 induction cycles
  • Urine monoclonal component ≥ 200mg/24h

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients

Cycle1 day1: collection of 24h urine and an urine sample from miction the day of the visit.

Cycle 2 day1:collection of 24h urine and an urine sample from miction the day of the visit Cycle 4 day 1: collection of 24h urine and an urine sample from miction the day of the visit.
Diagnostic test: Detection of monoclonal component
Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample
Time Frame: at the first Day of Cycle n°2 (each cycle is 28 days or 21 days)

Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample compared to the reference measurement of 24 hours urine.

Sensitivity is defined as the proportion, among the patients with positive urinalysis results on 24 hours urine, of positive results on spot urine sample. Evaluation is performed by urine protein electrophoresis and urine immunofixation
at the first Day of Cycle n°2 (each cycle is 28 days or 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the specificity of urine monoclonal component detection on spot urine sample
Time Frame: at the first Day of cycle n°2 (each cycle is 28 days or 21 days)

Evaluate the specificity of urine monoclonal component detection on sample at C2D1 compared to the reference measurement of 24 hours urine sample.

Specificity is defined as the proportion, among patients with negative urinalysis results on 24 hours urine, of negative results on the spot urine sample.
at the first Day of cycle n°2 (each cycle is 28 days or 21 days)
Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample
Time Frame: at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days)
Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample at C1D1 and C4D1 compared to reference measurement of 24hours urine sample
at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days)
Compare the responses rate
Time Frame: at the first day of cycle n° 2 and cycle 4 (each cycle is 28 days or 21 days)
Compare the rate of partial responses, very good partial responses and complete responses (IMWG criteria) but only on the urinary monoclonal component) at C2D1 and C4D1 between the two types of samples (spot urine sample and 24hours urine sample)
at the first day of cycle n° 2 and cycle 4 (each cycle is 28 days or 21 days)
Compare the monoclonal component / creatininuria ratios
Time Frame: at the first day of cycle n° 1,2 and 4
Compare the monoclonal component / creatininuria ratios in both samples (spot urine sample and 24hours urine sample) for components monoclonal which are quantifiable in both types of urine samples
at the first day of cycle n° 1,2 and 4
Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease)
Time Frame: at the first day of cycle n° 1 (each cycle is 28 days or 21 days)
Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease) at C1D1 and on the others points, if the monoclonal component is quantifiable)
at the first day of cycle n° 1 (each cycle is 28 days or 21 days)
Assess the association between the rate of serum light chains and concentration of monoclonal components
Time Frame: at first day of cycle 2 (each cycle is 28 days or 21 days)
To assess the association between serum light chains and concentration of monoclonal components for both types of urine samples.
at first day of cycle 2 (each cycle is 28 days or 21 days)
Evaluate the urine monoclonal component by the difference between proteinuria and albuminuria
Time Frame: at first day of cycle 2 (each cycle is 28 days or 21 days)
To Evaluate if the rate of urine monoclonal component (in g/L)could by calculated by the difference between proteinuria (in g/L) and albuminuria (in g/L)
at first day of cycle 2 (each cycle is 28 days or 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone du Myelome

Investigators

  • Principal Investigator: Olivier DECAUX, PU-PH, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFM 2020-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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