Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Diagnostic Test: Detection of monoclonal component
- Registration Number
- NCT05208086
- Lead Sponsor
- Intergroupe Francophone du Myelome
- Brief 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.
- 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.
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
-Patients with an emergency planned dexamethasone block administration before the first chemotherapy cycle initiation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Detection of monoclonal component 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.
- Primary Outcome Measures
Name Time Method Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample 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
- Secondary Outcome Measures
Name Time Method Evaluate the specificity of urine monoclonal component detection on spot urine sample 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.Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample 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
Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease) 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)
Assess the association between the rate of serum light chains and concentration of monoclonal components 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.
Compare the responses rate 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)
Compare the monoclonal component / creatininuria ratios 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
Evaluate the urine monoclonal component by the difference between proteinuria and albuminuria 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)
Trial Locations
- Locations (22)
Centre Hospitalier William Morey
🇫🇷Chalon Sur Saone, France
Centre Hospitalier Métropole de Savoie
🇫🇷Chambéry, France
Ch Le Mans
🇫🇷Le Mans, France
Chu Pontchaillou
🇫🇷Rennes, France
Hôpital E. MULLER
🇫🇷Mulhouse, France
CHRU Nantes
🇫🇷Nantes, France
CHU Poitiers
🇫🇷Poitiers, France
CHU de Reims
🇫🇷Reims, France
CHU Toulouse
🇫🇷Toulouse, France
CHRU Bretonneau
🇫🇷Tours, France
CH Bretagne Atlantique Vannes et Auray-P.Chubert
🇫🇷Vannes, France
CH de Versailles
🇫🇷Versailles, France
Ch Annecy Genevois
🇫🇷Annecy, France
CH de Dunkerque
🇫🇷Dunkerque, France
CHD Vendée
🇫🇷La Roche Sur Yon, France
CHU François Mitterand
🇫🇷Dijon, France
Hopital Bicètre
🇫🇷Le Kremlin Bicètre, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU saint Eloi
🇫🇷Montpellier, France
CH de Lens
🇫🇷Lens, France
Hopital Claude Huriez-CHRU LILLE
🇫🇷Lille, France
Centre Hospitalier Lyon sud
🇫🇷Lyon, France