Monoclonal Gammopathy of Renal SignificanceNCT05119309
MGRS: Clinical-histological Features of a Multicenter Case Series
An observational study of Monoclonal Gammopathy of Renal Significance, run by University of Milano Bicocca at 8 sites in Italy.
Trial summary
The term "Monoclonal Gammopathies of Renal Significance" (MGRS) describes a group of diseases characterized by the presence of an immunoglobulin or monoclonal immunoglobulin fraction that has the ability to cause renal damage. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Monoclonal Gammopathy of Renal Significance
- How many people
- 87 participants
- Where
- 8 sitesItaly
- Study dates
- 15 Jul 2021to 31 Oct 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a large series of patients with Monoclonal Gammopathies of Renal Significance treated with oncohematological therapy; this group will be compared with patients suffering from renal disease associated with oncohematological diseases with full clinical expression (multiple myeloma and B cell lymphomas) which produce monoclonal component and who have been treated according to the established specific schemes of each disease.
Who may be able to join
- Renal biopsy diagnosis of MGRS or disease linked to multiple myeloma and B cell lymphoma between 01/01/2010 and 31/12/2020 (for patient group)
- Renal biopsy diagnosis of nephropathy linked to onco-haematological pathology with full clinical expression (eg Multiple Myeloma, B-cell Lymphoma) between 01/01/2010 and 31/12/2021 (for control group);
- Age greater than or equal to 18 years;
- Informed consent freely granted and acquired before the start of the study.
Who cannot join
- Patients who do not meet the relevant inclusion criteria and who do not have an established diagnosis of MGRS or disease related to multiple myeloma and B-cell lymphoma will be excluded from the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
ASST Nord Milano, Presidio Ospedaliero Bassini
Cinisello Balsamo, Milano, 20092
ASST Monza, Ospedale di Desio
Desio, Monza E Brianza, 20832
ASST Lecco, Presidio Ospedaliero Alessandro Manzoni
Lecco, 23900
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
ASST Monza
Monza, 20900
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, 20089
ASST Lariana, Ospedale Sant' Anna
San Fermo della Battaglia, Como, 22020
ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi
Varese, 21100
About this study
Official title: Monoclonal Gammopathies of Renal Significance: Clinical-histological Features of a Multicenter Case Series (MGRS Project)
The term "Monoclonal Gammopathies of Renal Significance" (MGRS) describes a group of diseases characterized by the presence of an immunoglobulin or monoclonal immunoglobulin fraction that has the ability to cause renal damage.
It is important to diagnose MGRS correctly and early as renal survival depends on the renal function present at the time of diagnosis and it is necessary to establish a specific treatment that aims to stop the progression of the damage. organ and restoration of renal function.
Read more
To date, there are no targeted therapeutic strategies that can prevent the formation of deposits or that can eliminate the deposits already present in the kidney, which constitute the etiopathogenetic factor of these pathologies. Therefore, the only valid therapeutic option is to act against the clone of B lymphocytes underlying the nephrological pathology, although it is not a clone with such requirements to be able to define it as a tumor.
Therefore, given the absence of a well-defined policy in the therapy of MGRS and the doubts present on the validity of a therapeutic approach aimed at the suppression of a plasma cell clone, the investigators decided to carry out an observational retrospective study with the aim of describing, in a large series of MGRS treated with oncohematological therapy, the renal and overall outcome of patients and identify any presenting prognostic characteristics that can help improve the diagnosis of these disorders and the long-term survival of patients.
Read the detailed description
The group will be compared with patients suffering from renal disease associated with oncohematological diseases with full clinical expression (multiple myeloma and B cell lymphomas) which produce monoclonal component and who have been treated according to the established specific schemes of each disease.
The study will have a total duration of 12 months. It will analyze the data of the patients included in the clinical charts from 01/01/2010 to 31/12/2020. A total of 120 patients and 60 pathological controls will be enrolled (2:1 ratio), expected total number of patients from the centers participating in the study enrolled through the outpatient clinics of the Departments of the study.
The variables considered in the study are routine laboratory data (renal function, electrophoresis of serum and urinary proteins with immunofission, serum free light chains and their ratio, proteinuria 24 h serum albumin), clinical and anamnestic data, data on current drug therapy and description of renal biopsy characteristics using a predefined database with statistical analysis of data.
- Keywords
- MGRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient group | Renal biopsy diagnosis of MGRS or disease linked to multiple myeloma and B cell lymphoma | |
| control patient group | Renal biopsy diagnosis of nephropathy linked to onco-haematological pathology with full clinical expression (Multiple Myeloma, B-cell Lymphoma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pictures of biochemical presentation
Multicenter retrospective evaluation of biochemical presentation pictures of patients with MGRS and clinically expressed haematological diseases, with renal involvement
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Evaluation of the renal status of study patients using physiological parameters (use of the eGFR in ml / min / 1.73 m2 calculated with CKD-EPI)
Renal and global health outcomes of patients with MGRS, comparison with patients with haematological diseases
Measured: through study completion, an average of 1 year
Evaluation of the global health of study patients using physiological parameters (use of the eGFR in ml / min / 1.73 m2 calculated with CKD-EPI)
Renal and global health outcomes of patients with MGRS, comparison with patients with haematological diseases
Measured: through study completion, an average of 1 year
Prognostic characteristics
Identification of any prognostic characteristics of presentation
Measured: through study completion, an average of 1 year
Biochemical indicators of response to treatment
Identification of any biochemical indicators of response to treatment (serum and urinary protein electrophoresis and 24 h proteinuria to evaluate renal function)
Measured: through study completion, an average of 1 year
Clinical indicators of response to treatment
Identification of any biochemical and clinical indicators of response to treatment (serum and urinary protein electrophoresis and 24 h proteinuria to evaluate renal function)
Measured: through study completion, an average of 1 year
Therapies
Description of the therapies applied in the treatment of pathologies, report of side effects
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start15 Jul 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Renal SignificanceStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato A Sinico, MD, Principal investigator, Università degli Studi di Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119309
- Sponsor's protocol ID
- MGRS
- Status last verified
- Dec 2023
- First submitted
- 29 Jul 2021
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monoclonal Gammopathies of Renal Significance: Clinical-histological Features of a Multicenter Case Series (MGRS Project)
- ClinicalTrials.gov ID
- NCT05119309
- Acronym / sponsor ID
- MGRS
- Keywords
- MGRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- 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 term "Monoclonal Gammopathies of Renal Significance" (MGRS) describes a group of diseases characterized by the presence of an immunoglobulin or monoclonal immunoglobulin fraction that has the ability to cause renal damage.
It is important to diagnose MGRS correctly and early as renal survival depends on the renal function present at the time of diagnosis and it is necessary to establish a specific treatment that aims to stop the progression of the damage. organ and restoration of renal function.
To date, there are no targeted therapeutic strategies that can prevent the formation of deposits or that can eliminate the deposits already present in the kidney, which constitute the etiopathogenetic factor of these pathologies. Therefore, the only valid therapeutic option is to act against the clone of B lymphocytes underlying the nephrological pathology, although it is not a clone with such requirements to be able to define it as a tumor.
Therefore, given the absence of a well-defined policy in the therapy of MGRS and the doubts present on the validity of a therapeutic approach aimed at the suppression of a plasma cell clone, the investigators decided to carry out an observational retrospective study with the aim of describing, in a large series of MGRS treated with oncohematological therapy, the renal and overall outcome of patients and identify any presenting prognostic characteristics that can help improve the diagnosis of these disorders and the long-term survival of patients.
Detailed description
The group will be compared with patients suffering from renal disease associated with oncohematological diseases with full clinical expression (multiple myeloma and B cell lymphomas) which produce monoclonal component and who have been treated according to the established specific schemes of each disease.
The study will have a total duration of 12 months. It will analyze the data of the patients included in the clinical charts from 01/01/2010 to 31/12/2020. A total of 120 patients and 60 pathological controls will be enrolled (2:1 ratio), expected total number of patients from the centers participating in the study enrolled through the outpatient clinics of the Departments of the study.
The variables considered in the study are routine laboratory data (renal function, electrophoresis of serum and urinary proteins with immunofission, serum free light chains and their ratio, proteinuria 24 h serum albumin), clinical and anamnestic data, data on current drug therapy and description of renal biopsy characteristics using a predefined database with statistical analysis of data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | –Renal biopsy diagnosis of MGRS or disease linked to multiple myeloma and B cell lymphoma |
| control patient group | – | –Renal biopsy diagnosis of nephropathy linked to onco-haematological pathology with full clinical expression (Multiple Myeloma, B-cell Lymphoma) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a large series of patients with Monoclonal Gammopathies of Renal Significance treated with oncohematological therapy; this group will be compared with patients suffering from renal disease associated with oncohematological diseases with full clinical expression (multiple myeloma and B cell lymphomas) which produce monoclonal component and who have been treated according to the established specific schemes of each disease.
Key inclusion criteria (4 listed)
- Renal biopsy diagnosis of MGRS or disease linked to multiple myeloma and B cell lymphoma between 01/01/2010 and 31/12/2020 (for patient group)
- Renal biopsy diagnosis of nephropathy linked to onco-haematological pathology with full clinical expression (eg Multiple Myeloma, B-cell Lymphoma) between 01/01/2010 and 31/12/2021 (for control group);
- Age greater than or equal to 18 years;
- Informed consent freely granted and acquired before the start of the study.
Key exclusion criteria (1 listed)
- Patients who do not meet the relevant inclusion criteria and who do not have an established diagnosis of MGRS or disease related to multiple myeloma and B-cell lymphoma will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of pictures of biochemical presentation
Time frame: through study completion, an average of 1 year
Multicenter retrospective evaluation of biochemical presentation pictures of patients with MGRS and clinically expressed haematological diseases, with renal involvement
6 secondary outcomes
Evaluation of the renal status of study patients using physiological parameters (use of the eGFR in ml / min / 1.73 m2 calculated with CKD-EPI)
Time frame: through study completion, an average of 1 year
Evaluation of the global health of study patients using physiological parameters (use of the eGFR in ml / min / 1.73 m2 calculated with CKD-EPI)
Time frame: through study completion, an average of 1 year
Prognostic characteristics
Time frame: through study completion, an average of 1 year
Biochemical indicators of response to treatment
Time frame: through study completion, an average of 1 year
Clinical indicators of response to treatment
Time frame: through study completion, an average of 1 year
Therapies
Time frame: through study completion, an average of 1 year
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 2 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Monoclonal Gammopathy of Renal Significance
RecruitingPhase 2
The Effect of Daratumumab in Patients With Monoclonal Gammopathy of Renal Significance (MGRS) in Finland
Kidney Failure, Paraproteinemias
RecruitingObservational study
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
Multiple Myeloma, Amyloidosis
Active, not recruitingPhase 2
Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
Monoclonal Gammopathy
RecruitingPhase 2
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
Multiple Myeloma, Monoclonal Gammopathy of Renal Significance
Not yet recruitingPhase 2
Dara-BCD for Rare MGRS
Monoclonal Gammopathy of Renal Significance (MGRS)
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.
Renato A Sinico, MD principal investigator
Università degli Studi di Milano Bicocca
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathy of Renal Significance, run by University of Milano Bicocca at 8 sites in Italy.
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 4 inclusion and 1 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
Assessment of pictures of biochemical presentation (time frame: through study completion, an average of 1 year). 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 2 Jan 2024.