Multiple MyelomaRHUMMNCT05208086
Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Intergroupe Francophone du Myelome at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Detection of monoclonal component
- How many people
- 180 participants
- Where
- 18 sitesFrance
- Study dates
- 18 May 2022to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Multiple Myeloma whatever the line of treatment started in one of the twenty investigators sites located in France.
Who may be able to join
- 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
Who cannot join
- Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Ch Annecy Genevois
Annecy
Centre Hospitalier Métropole de Savoie
Chambéry
CHU François Mitterand
Dijon
CH de Dunkerque
Dunkirk
CHD Vendée
La Roche-sur-Yon
Hopital Bicètre
Le Kremlin Bicètre
Ch Le Mans
Le Mans
CH de Lens
Lens
Hopital Claude Huriez-CHRU LILLE
Lille
Centre Hospitalier Lyon sud
Lyon
CHU de Montpellier
Montpellier
Hôpital E. MULLER
Mulhouse
CHRU Nantes
Nantes
Chu Pontchaillou
Rennes
CHU Toulouse
Toulouse
CHRU Bretonneau
Tours
CH Bretagne Atlantique Vannes et Auray-P.Chubert
Vannes
CH de Versailles
Versailles
About this study
Official title: 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.
Read the 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).
- Conditions
- Multiple Myeloma
- Being tested
- Detection of monoclonal component
- Keywords
- Multiple Myeloma, Monoclonal components detection, Urine sample
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of monoclonal componentDiagnostic test
Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Detection of monoclonal component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample
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
Measured: at the first Day of Cycle n°2 (each cycle is 28 days or 21 days)
Secondary outcomes (7)
Evaluate the specificity of urine monoclonal component detection on spot urine sample
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.
Measured: 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
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
Measured: at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days)
Compare the responses rate
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)
Measured: 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
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
Measured: 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)
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)
Measured: 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
To assess the association between serum light chains and concentration of monoclonal components for both types of urine samples.
Measured: 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
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)
Measured: at first day of cycle 2 (each cycle is 28 days or 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start18 May 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Olivier DECAUX, PU-PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208086
- Sponsor's protocol ID
- IFM 2020-03
- Acronym
- RHUMM
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05208086
- Acronym / sponsor ID
- RHUMM / IFM 2020-03
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Monoclonal components detection, Urine sample
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Intergroupe Francophone du MyelomeResearch network
- Study start
- 18 May 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Detection of monoclonal componentCycle1 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Multiple Myeloma whatever the line of treatment started in one of the twenty investigators sites located in France.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of monoclonal componentMonoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample. | Diagnostic test | Patients |
Primary outcome
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
7 secondary outcomes
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 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)
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 monoclonal component / creatininuria ratios
Time frame: 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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier DECAUX, PU-PH principal investigator
Rennes University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Intergroupe Francophone du Myelome at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.