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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Diagnostic Test: Detection of monoclonal component


Participation Criteria
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Eligibility Criteria
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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: -Patients with an emergency planned dexamethasone block administration before the first chemotherapy cycle initiation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>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<br>* Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Monoclonal components detection, Urine sample