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

Multiple Myeloma Clinical Trial

— RHUMM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208086
• Other study ID #: IFM 2020-03
• Status: Recruiting
• Start date: May 18, 2022
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Intergroupe Francophone du Myelome
• Contact: amandine huguet
• Phone: 0531156338
• Email: a.huguet[@]myelome.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Diagnostic Test:
• Detection of monoclonal component
Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.

Locations

Country	Name	City	State
France	Ch Annecy Genevois	Annecy
France	Centre Hospitalier William Morey	Chalon Sur Saone
France	Centre Hospitalier Métropole de Savoie	Chambéry
France	CHU François Mitterand	Dijon
France	CH de Dunkerque	Dunkerque
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	CHU saint Eloi	Montpellier
France	Hôpital E. MULLER	Mulhouse
France	CHRU Nantes	Nantes
France	CHU Poitiers	Poitiers
France	CHU de Reims	Reims
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

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone du Myelome

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)