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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

-Patients with an emergency planned dexamethasone block administration before the first chemotherapy cycle initiation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05208086
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Intergroupe Francophone du Myelome
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Olivier DECAUX, PU-PH
Principal Investigator Affiliation Rennes University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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).

Arms & Interventions

Arms

: 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.

Interventions

Diagnostic Test: - Detection of monoclonal component

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ch Annecy Genevois, Annecy, France

Status

Recruiting

Address

Ch Annecy Genevois

Annecy, ,

Site Contact

Frédérique ORSINI PIOCELLE, MD

a.huguet@myelome.fr

0531156338

Centre Hospitalier William Morey, Chalon Sur Saone, France

Status

Active, not recruiting

Address

Centre Hospitalier William Morey

Chalon Sur Saone, ,

Centre Hospitalier Métropole de Savoie, Chambéry, France

Status

Recruiting

Address

Centre Hospitalier Métropole de Savoie

Chambéry, ,

Site Contact

Arthur DONNY

a.huguet@myelome.fr

0531156338

CHU François Mitterand, Dijon, France

Status

Recruiting

Address

CHU François Mitterand

Dijon, ,

Site Contact

Marie-Lorraine CHRETIEN, MD

a.huguet@myelome.fr

0531156338

CH de Dunkerque, Dunkerque, France

Status

Active, not recruiting

Address

CH de Dunkerque

Dunkerque, ,

CHD Vendée, La Roche Sur Yon, France

Status

Recruiting

Address

CHD Vendée

La Roche Sur Yon, ,

Site Contact

Mouad TIAB

a.huguet@myelome.fr

0531156338

Hopital Bicètre, Le Kremlin Bicètre, France

Status

Recruiting

Address

Hopital Bicètre

Le Kremlin Bicètre, ,

Site Contact

Rakiba BELKHIR, MD

a.huguet@myelome.fr

0531156338

Ch Le Mans, Le Mans, France

Status

Recruiting

Address

Ch Le Mans

Le Mans, ,

Site Contact

Kamel LARIBI, MD

a.huguet@myelome.fr

0531156338

CH de Lens, Lens, France

Status

Recruiting

Address

CH de Lens

Lens, ,

Site Contact

Daniela ROBU

a.huguet@myelome.fr

0531156338

Hopital Claude Huriez-CHRU LILLE, Lille, France

Status

Active, not recruiting

Address

Hopital Claude Huriez-CHRU LILLE

Lille, ,

Centre Hospitalier Lyon sud, Lyon, France

Status

Recruiting

Address

Centre Hospitalier Lyon sud

Lyon, ,

Site Contact

Lionel Karlin, MD

a.huguet@myelome.fr

0531156338

CHU de Montpellier, Montpellier, France

Status

Recruiting

Address

CHU de Montpellier

Montpellier, ,

Site Contact

Laure VINCENT, MD

a.huguet@myelome.fr

0531156338

CHU saint Eloi, Montpellier, France

Status

Not yet recruiting

Address

CHU saint Eloi

Montpellier, ,

Site Contact

Laure Vincent

a.huguet@myelome.fr

0531156338

Hôpital E. MULLER, Mulhouse, France

Status

Recruiting

Address

Hôpital E. MULLER

Mulhouse, ,

Site Contact

Muriel Newinger-Porte

a.huguet@myelome.fr

0531156338

CHRU Nantes, Nantes, France

Status

Recruiting

Address

CHRU Nantes

Nantes, ,

Site Contact

Cyrille TOUZEAU, MD

a.huguet@myelome.fr

0531156338

CHU Poitiers, Poitiers, France

Status

Not yet recruiting

Address

CHU Poitiers

Poitiers, ,

Site Contact

Xavier LELEU, MD

a.huguet@myelome.fr

0531156338

CHU de Reims, Reims, France

Status

Active, not recruiting

Address

CHU de Reims

Reims, ,

Chu Pontchaillou, Rennes, France

Status

Active, not recruiting

Address

Chu Pontchaillou

Rennes, ,

CHU Toulouse, Toulouse, France

Status

Recruiting

Address

CHU Toulouse

Toulouse, ,

Site Contact

Aurore Perrot, MD

a.huguet@myelome.fr

0531156338

CHRU Bretonneau, Tours, France

Status

Recruiting

Address

CHRU Bretonneau

Tours, ,

Site Contact

Thomas CHALOPIN, MD

a.huguet@myelome.fr

0531156338

Vannes, France

Status

Recruiting

Address

CH Bretagne Atlantique Vannes et Auray-P.Chubert

Vannes, ,

Site Contact

Brieuc CHEREL, MD

a.huguet@myelome.fr

0531156338

CH de Versailles, Versailles, France

Status

Not yet recruiting

Address

CH de Versailles

Versailles, ,

Site Contact

Sophie Rigaudeau, MD

a.huguet@myelome.fr

0531156338