Urinary Protein/Creatinine Ratio in a Single Urine Sample Versus 24-hour Proteinuria in Patients With Multiple Myeloma

NCT01572857 | Completed

• 1 other identifier: 201O-AOI354-35
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The measurement of 24-hour proteinuria allows an assessment of treatment response in patients with multiple myeloma. But it is difficult and restrictive to make. This study was therefore designed to investigate the correlation between the ratio of proteinuria / creatinine on samples, easier to obtain, and the 24-hour proteinuria in assessing response to this treatment .

Conditions

Multiple Myeloma

Keywords

multiple myeloma; Proteinuria; Albuminuria; Urinary FLC; Urine creatinine

Outcome Measures

Primary Outcomes (1)

• change in urinary protein/creatinine ratio

  To study the correlation between the urinary protein/creatinine ratio in the sample and 24-hour proteinuria in the assessment of treatment response in patients with multiple myeloma.

  Change from baseline in urinary protein/creatinine ratio at 8 AM, 12 AM, 4 PM

Secondary Outcomes (2)

• changes in urinary excretion of FLC

  Of the 24-hour urine, at 8 AM, 12 AM, 4 PM

• methods for estimating the urinary concentration of FLC

  Of the 24-hour urine, at 8 AM, 12 AM, 4 PM

Study Arms (2)

first phase

This first phase aims to study the variations in urinary excretion of FLC immunoglobulin during the day and night to determine the appropriate time of day for collection of urine. 20 patients hospitalized.

Biological: urinary excretion of FLC immunoglobulin

Second phase

Determination of creatinine in 24 hours by measuring the creatinine of 24 hours 3 days in a row. This value will check the quality of urine collection for 24 hours during the study. 30 patients hospitalized.

Biological: urinary excretion of FLC immunoglobulin

Interventions

urinary excretion of FLC immunoglobulin BIOLOGICAL

First phase : Collection of four urine samples daily for 2 days: * Of the 24-hour urine * at 8 AM * at 12 AM * at 4 PM On each of these urine samples, the following analysis will be performed: * Proteinuria * Albuminuria * Urinary FLC (Freelite ™) * Urine creatinine Second phase: Determination of creatinine in 24 hours by measuring the creatinine of 24 hours 3 days in a row.

Also known as: Non applicable.

Second phase; first phase

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

Patients with multiple myeloma.

You may qualify if:

• For the first part of the study :
• adult patient
• giving a free, informed and written consent
• patient having a follow-up in the service for multiple myeloma, whatever the age of diagnosis, the isotype of monoclonal component, stage and disease activity
• patient hospitalized in the service whatever the reason for hospitalization (related or not with multiple myeloma)
• proteinuria ≥ 500 mg/24h
• percentage of albuminuria \< 50% on urinary protein electrophoresis
• presence of immunoglobulin FLC in immunofixation of urine proteins
• For the second part of the study :
• adult patient
• giving a free, informed and written consent
• patient having a follow-up in the service for multiple myeloma, whatever the age of diagnosis, the isotype of monoclonal component
• requiring the initiation of treatment with chemotherapy
• proteinuria ≥ 500 mg/24h
• percentage of albuminuria \< 50% on urinary protein electrophoresis

You may not qualify if:

• minor patient
• proteinuria \< 500 mg/24h
• predominantly glomerular proteinuria with ≥ 50% albumin on urinary protein electrophoresis
• absence of immunoglobulin FLC in urine proteins immunofixation
• progressive urinary infection
• patient with a glomerular nephropathy
• macroscopic hematuria
• patient unable to perform a urinary collection for 24 hours
• patient unable to give a consent
• pregnant or lactating woman

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Service de Médecine interne - Hôpital Sud : Rennes University Hospital

Rennes, 35000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Proteinuria * Albuminuria * Urinary FLC (Freelite ™) * Urine creatinine

MeSH Terms

Conditions

Multiple Myeloma; Proteinuria; Albuminuria

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; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier DECAUX, MD

  Service de Medecine interne - Hôpital Sud - Rennes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 6, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

FR (1)