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

Recruiting

• Conditions: Multiple Myeloma

• 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).

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-05-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 (20)

Ch Annecy Genevois; 🇫🇷 Annecy, France

Centre Hospitalier William Morey; 🇫🇷 Chalon Sur Saone, France

Centre Hospitalier Métropole de Savoie; 🇫🇷 Chambéry, France

CHU François Mitterand; 🇫🇷 Dijon, France

CH de Dunkerque; 🇫🇷 Dunkerque, France

CHD Vendée; 🇫🇷 La Roche Sur Yon, France

Hopital Bicètre; 🇫🇷 Le Kremlin Bicètre, France

Ch Le Mans; 🇫🇷 Le Mans, France

CH de Lens; 🇫🇷 Lens, France

Hopital Claude Huriez-CHRU LILLE; 🇫🇷 Lille, France

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