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

September 10, 2018 updated by: Rennes University Hospital

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The measure of 24-hour proteinuria is an important biomarker for multiple myeloma.

Multiple myeloma is often accompanied by proteinuria overhead of secretion by plasma cells of large quantities of immunoglobulin free light chains (FLC) kappa or lambda. This proteinuria is composed of monoclonal FLC. The measure of the urinary concentration of FLC is an important biomarker for both diagnosis and evaluation of response to treatment of light chain multiple myeloma but also in intact immunoglobulins multiple myeloma.

The 24-hour proteinuria coupled with urine protein electrophoresis is the standard method for measuring the concentration of urinary FLC. However, it is difficult to obtain a reliable collection of the urine of 24 hours which can make it difficult to assess response to therapy in some patients. It would be interesting to assess proteinuria in a single urine sample collected at any time of day.

Contribution of urinary protein/creatinine ratio for assessment of proteinuria of glomerular origine.

For reasons of convenience, the extent of 24-hour proteinuria was increasingly abandoned by nephrologists in favor of urinary protein/creatinine ratio (UPCR). The use of UPCR measured on a sample of urine overcomes the inaccuracies related to the collection of 24 or variations in urine concentration. This report has been validated against the 24-hour proteinuria for screening or monitoring of renal glomerular diseases by the French Society of Nephrology. In theory, the UPCR is measured on a urine sample, taken preferably in the morning. In practice, the precision of a measurement at any time of day is quite acceptable.

Using the urinary protein/creatinine ratio for assessment of response in multiple myeloma?

The use of UPCR has been validated in patients with renal glomerular disease and especially in diabetic nephropathy. However, the UPCR has not been validated for the assessment of proteinuria overload such as those seen in myeloma. Two recent papers have studied the UPCR in multiple myeloma. The results of these articles suggest:

  • That the UPCR is well correlated with the 24-hour proteinuria
  • The UPCR varies over time depending on the response to treatment and could therefore be used to monitor patients on treatment

However, given their limits, these two articles do not alow to recommend the widespread use of UPCR instead of the classic 24-hour proteinuria in clinical practice yet. Prospective studies are needed to analyze the correlation between UPCR and proteinuria of 24 hours to assess response to therapy.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Service de Médecine interne - Hôpital Sud : Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple myeloma.

Description

Inclusion Criteria:

  • 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
    • presence of immunoglobulin FLC in urine proteins immunofixation

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

Other Names:
  • Non applicable.
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

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.

Other Names:
  • Non applicable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in urinary protein/creatinine ratio
Time Frame: Change from baseline in urinary protein/creatinine ratio at 8 AM, 12 AM, 4 PM
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in urinary excretion of FLC
Time Frame: Of the 24-hour urine, at 8 AM, 12 AM, 4 PM
To study the changes in urinary excretion of FLC during the day and night
Of the 24-hour urine, at 8 AM, 12 AM, 4 PM
methods for estimating the urinary concentration of FLC
Time Frame: Of the 24-hour urine, at 8 AM, 12 AM, 4 PM
Compare different methods for estimating the urinary concentration of FLC
Of the 24-hour urine, at 8 AM, 12 AM, 4 PM

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Olivier DECAUX, MD, Service de Medecine interne - Hôpital Sud - Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201O-AOI354-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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