RHUMM: Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: Detection of monoclonal component
Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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.
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient with Multiple Myeloma
-
Patient starting new treatment line, whatever the line is, but with at least 3 induction cycles
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Urine monoclonal component ≥ 200mg/24h
Exclusion Criteria:
-Patients with an emergency planned dexamethasone block administration before the first chemotherapy cycle initiation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ch Annecy Genevois | Annecy | France | ||
| 2 | Centre Hospitalier William Morey | Chalon Sur Saone | France | ||
| 3 | Centre Hospitalier Métropole de Savoie | Chambéry | France | ||
| 4 | CHU François Mitterand | Dijon | France | ||
| 5 | CH de Dunkerque | Dunkerque | France | ||
| 6 | CHD Vendée | La Roche Sur Yon | France | ||
| 7 | Hopital Bicètre | Le Kremlin Bicètre | France | ||
| 8 | Ch Le Mans | Le Mans | France | ||
| 9 | CH de Lens | Lens | France | ||
| 10 | Hopital Claude Huriez-CHRU LILLE | Lille | France | ||
| 11 | Centre Hospitalier Lyon sud | Lyon | France | ||
| 12 | CHU saint Eloi | Montpellier | France | ||
| 13 | Hôpital E. MULLER | Mulhouse | France | ||
| 14 | CHRU Nantes | Nantes | France | ||
| 15 | CHU Poitiers | Poitiers | France | ||
| 16 | CHU de Reims | Reims | France | ||
| 17 | Chu Pontchaillou | Rennes | France | ||
| 18 | CHU Toulouse | Toulouse | France | ||
| 19 | CHRU Bretonneau | Tours | France | ||
| 20 | CH Bretagne Atlantique Vannes et Auray-P.Chubert | Vannes | France |
Sponsors and Collaborators
- Intergroupe Francophone du Myelome
Investigators
- Principal Investigator: Olivier DECAUX, PU-PH, Rennes University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IFM 2020-03