Multiple MyelomaRCP-MMNCT01572857
Urinary Protein/Creatinine Ratio in a Single Urine Sample Versus 24-hour Proteinuria in Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Rennes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- urinary excretion of FLC immunoglobulin
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple myeloma.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- macroscopic hematuria
- patient unable to perform a urinary collection for 24 hours
- patient unable to give a consent
- pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine interne - Hôpital Sud : Rennes University Hospital
Rennes, 35000
About this study
Official title: 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 .
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- urinary excretion of FLC immunoglobulin
- Keywords
- multiple myeloma, Proteinuria, Albuminuria, Urinary FLC, Urine creatinine
- Medical subject headings
- Multiple Myeloma, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary excretion of FLC immunoglobulinBiological
Also called Non applicable.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: urinary excretion of FLC immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in urinary protein/creatinine ratio at 8 AM, 12 AM, 4 PM
Secondary outcomes (2)
changes in urinary excretion of FLC
To study the changes in urinary excretion of FLC during the day and night
Measured: Of the 24-hour urine, at 8 AM, 12 AM, 4 PM
methods for estimating the urinary concentration of FLC
Compare different methods for estimating the urinary concentration of FLC
Measured: Of the 24-hour urine, at 8 AM, 12 AM, 4 PM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier DECAUX, MD, Principal investigator, Service de Medecine interne - Hôpital Sud - Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572857
- Sponsor's protocol ID
- 201O-AOI354-35
- Acronym
- RCP-MM
- Status last verified
- Sep 2018
- First submitted
- 28 Mar 2012
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Urinary Protein/Creatinine Ratio in a Single Urine Sample Versus 24-hour Proteinuria in Patients With Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT01572857
- Acronym / sponsor ID
- RCP-MM / 201O-AOI354-35
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Proteinuria, Albuminuria, Urinary FLC, Urine creatinine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first phase | – | Biological: urinary excretion of FLC immunoglobulinThis 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. |
| Second phase | – | Biological: urinary excretion of FLC immunoglobulinDetermination 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma.
Key inclusion criteria (16 listed)
- For the first part of the study :
- For the second part of the study :
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urinary excretion of FLC immunoglobulinAlso: Non applicable.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. | Biological | Second phase, first phase |
Primary outcome
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.
2 secondary outcomes
changes in urinary excretion of FLC
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier DECAUX, MD principal investigator
Service de Medecine interne - Hôpital Sud - Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in urinary protein/creatinine ratio (time frame: Change from baseline in urinary protein/creatinine ratio at 8 AM, 12 AM, 4 PM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.