An observational study in Multiple Myeloma, sponsored by Intergroupe Francophone du Myelome. Active, not recruiting at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Intergroupe Francophone du Myelome · Observational
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.
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).
Patient with Multiple Myeloma whatever the line of treatment started in one of the twenty investigators sites located in France.
Exclusion Criteria:
Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
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.
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
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 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.
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
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
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
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)
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
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
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)
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)
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
To assess the association between serum light chains and concentration of monoclonal components for both types of urine samples.
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
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)
Time frame: at first day of cycle 2 (each cycle is 28 days or 21 days)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intergroupe Francophone du Myelome