Evaluating urine samples for detecting monoclonal components in multiple myeloma patients
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
Intergroupe Francophone du Myelome · NCT05208086
This study is testing if quick urine samples can reliably detect certain proteins in people with multiple myeloma, compared to the usual method of collecting urine over 24 hours.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intergroupe Francophone du Myelome (network) |
| Locations | 20 sites (Annecy and 19 other locations) |
| Trial ID | NCT05208086 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the sensitivity of detecting urinary monoclonal components using spot urine samples compared to the traditional 24-hour urine collection in patients diagnosed with Multiple Myeloma. A total of 300 patients will provide both types of urine samples at specified intervals during their treatment cycles. The detection methods employed include urine protein electrophoresis for quantitative analysis and urine immunofixation for qualitative assessment. The goal is to determine if spot urine samples can serve as a reliable alternative for monitoring this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Multiple Myeloma who are starting a new treatment line and have a urine monoclonal component level of at least 200mg/24h.
Not a fit: Patients who are under guardianship or have legal restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could simplify the monitoring process for patients with Multiple Myeloma by using less invasive urine samples.
How similar studies have performed: While the approach of using spot urine samples is gaining interest, this specific evaluation of its sensitivity compared to 24-hour collections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Annecy and 19 other locations
- Ch Annecy Genevois — Annecy, France (RECRUITING)
- Centre Hospitalier William Morey — Chalon Sur Saone, France (WITHDRAWN)
- Centre Hospitalier Métropole de Savoie — Chambéry, France (RECRUITING)
- CHU François Mitterand — Dijon, France (RECRUITING)
- CH de Dunkerque — Dunkerque, France (RECRUITING)
- CHD Vendée — La Roche Sur Yon, France (RECRUITING)
- Hopital Bicètre — Le Kremlin Bicètre, France (RECRUITING)
- Ch Le Mans — Le Mans, France (RECRUITING)
- CH de Lens — Lens, France (RECRUITING)
- Hopital Claude Huriez-CHRU LILLE — Lille, France (RECRUITING)
- Centre Hospitalier Lyon sud — Lyon, France (RECRUITING)
- CHU de Montpellier — Montpellier, France (RECRUITING)
- Hôpital E. MULLER — Mulhouse, France (RECRUITING)
- CHRU Nantes — Nantes, France (RECRUITING)
- CHU de Reims — Reims, France (WITHDRAWN)
- Chu Pontchaillou — Rennes, France (RECRUITING)
- CHU Toulouse — Toulouse, France (RECRUITING)
- CHRU Bretonneau — Tours, France (RECRUITING)
- CH Bretagne Atlantique Vannes et Auray-P.Chubert — Vannes, France (RECRUITING)
- CH de Versailles — Versailles, France (RECRUITING)
Study contacts
- Principal investigator: Olivier DECAUX, PU-PH — Rennes University Hospital
- Study coordinator: Frederique Franco
- Email: f.franco@myelome.fr
- Phone: 0140212402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Monoclonal components detection, Urine sample