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

Intergroupe Francophone du Myelome

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Diagnostic Test: Detection of monoclonal component

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05208086

IFM 2020-03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

Patients

Description:

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.

Treatment:

Diagnostic Test: Detection of monoclonal component