Clinical trial NCT05208086: Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Monoclonal components detection
Urine sample
Lead sponsor: Intergroupe Francophone du Myelome
Sponsor class: NETWORK
First posted: 2022-01-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Multiple Myeloma whatever the line of treatment started in one of the twenty investigators sites located in France.

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).

Eligibility 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

Primary outcomes:
measure: Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample
timeFrame: at the first Day of Cycle n°2 (each cycle is 28 days or 21 days)
Secondary outcomes:
measure: Evaluate the specificity of urine monoclonal component detection on spot urine sample
timeFrame: at the first Day of cycle n°2 (each cycle is 28 days or 21 days)
measure: Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample
timeFrame: at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days)
measure: Compare the responses rate
timeFrame: at the first day of cycle n° 2 and cycle 4 (each cycle is 28 days or 21 days)
measure: Compare the monoclonal component / creatininuria ratios
timeFrame: at the first day of cycle n° 1,2 and 4
measure: Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease)
timeFrame: at the first day of cycle n° 1 (each cycle is 28 days or 21 days)
measure: Assess the association between the rate of serum light chains and concentration of monoclonal components
timeFrame: at first day of cycle 2 (each cycle is 28 days or 21 days)
measure: Evaluate the urine monoclonal component by the difference between proteinuria and albuminuria
timeFrame: at first day of cycle 2 (each cycle is 28 days or 21 days)
Other outcomes:
Locations:
city: Annecy
country: France
facility: Ch Annecy Genevois
city: Chalon Sur Saone
country: France
facility: Centre Hospitalier William Morey
city: Chambéry
country: France
facility: Centre Hospitalier Métropole de Savoie
city: Dijon
country: France
facility: CHU François Mitterand
city: Dunkerque
country: France
facility: CH de Dunkerque
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Le Kremlin Bicètre
country: France
facility: Hopital Bicètre
city: Le Mans
country: France
facility: Ch Le Mans
city: Lens
country: France
facility: CH de Lens
city: Lille
country: France
facility: Hopital Claude Huriez-CHRU LILLE
city: Lyon
country: France
facility: Centre Hospitalier Lyon sud
city: Montpellier
country: France
facility: CHU de Montpellier
city: Mulhouse
country: France
facility: Hôpital E. MULLER
city: Nantes
country: France
facility: CHRU Nantes
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: Chu Pontchaillou
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Bretonneau
city: Vannes
country: France
facility: CH Bretagne Atlantique Vannes et Auray-P.Chubert
city: Versailles
country: France
facility: CH de Versailles
Study officials:
affiliation: Rennes University Hospital
name: Olivier DECAUX, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: