NCT05208086

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Intergroupe Francophone du Myelome · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Detection of monoclonal component	Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.

Timeline

• Start date: 2022-05-18
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-01-26
• Last updated: 2026-04-13

Locations

18 sites across 1 country: France