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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detection of monoclonal component | Diagnostic Test | Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
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Patient with Multiple Myeloma whatever the line of treatment started in one of the twenty investigators sites located in France.
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| Name | Affiliation | Role |
|---|---|---|
| Olivier DECAUX, PU-PH | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Annecy Genevois | Annecy | France | ||||
| Centre Hospitalier Métropole de Savoie |
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| 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) |
| Chambéry |
| France |
| CHU François Mitterand | Dijon | France |
| CH de Dunkerque | Dunkirk | 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 |
| Centre Hospitalier Lyon sud | Lyon | France |
| CHU de Montpellier | Montpellier | France |
| Hôpital E. MULLER | Mulhouse | France |
| CHRU Nantes | Nantes | France |
| Chu Pontchaillou | Rennes | France |
| CHU Toulouse | Toulouse | France |
| CHRU Bretonneau | Tours | France |
| CH Bretagne Atlantique Vannes et Auray-P.Chubert | Vannes | France |
| CH de Versailles | Versailles | France |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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