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

NCT05208086 | Active Not Recruiting

• 1 other identifier: IFM 2020-03
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 18

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Monoclonal components detection; Urine sample

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Evaluate the specificity of urine monoclonal component detection on spot urine sample

  at the first Day of cycle n°2 (each cycle is 28 days or 21 days)

• Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample

  at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days)

• Compare the responses rate

  at the first day of cycle n° 2 and cycle 4 (each cycle is 28 days or 21 days)

• Compare the monoclonal component / creatininuria ratios

  at the first day of cycle n° 1,2 and 4

• Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease)

  at the first day of cycle n° 1 (each cycle is 28 days or 21 days)

Study Arms (1)

Patients

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.

Diagnostic Test: Detection of monoclonal component

Interventions

Detection of monoclonal component DIAGNOSTIC_TEST

Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Sponsors & Collaborators

• Intergroupe Francophone du Myelome: lead

Study Sites (18)

Ch Annecy Genevois

Annecy, France

Location

Centre Hospitalier Métropole de Savoie

Chambéry, France

Location

CHU François Mitterand

Dijon, France

Location

CH de Dunkerque

Dunkirk, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Hopital Bicètre

Le Kremlin Bicètre, France

Location

Ch Le Mans

Le Mans, France

Location

CH de Lens

Lens, France

Location

Hopital Claude Huriez-CHRU LILLE

Lille, France

Location

Centre Hospitalier Lyon sud

Lyon, France

Location

CHU de Montpellier

Montpellier, France

Location

Hôpital E. MULLER

Mulhouse, France

Location

CHRU Nantes

Nantes, France

Location

Chu Pontchaillou

Rennes, France

Location

CHU Toulouse

Toulouse, France

Location

CHRU Bretonneau

Tours, France

Location

CH Bretagne Atlantique Vannes et Auray-P.Chubert

Vannes, France

Location

CH de Versailles

Versailles, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Olivier DECAUX, PU-PH

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 26, 2022
• Study Start: May 18, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (18)