MGRS: Clinical-histological Features of a Multicenter Case Series

NCT05119309 | Completed

• 1 other identifier: MGRS
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Monoclonal Gammopathy of Renal Significance

Keywords

MGRS

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  through study completion, an average of 1 year

• Prognostic characteristics

  through study completion, an average of 1 year

• Biochemical indicators of response to treatment

  through study completion, an average of 1 year

• Clinical indicators of response to treatment

  through study completion, an average of 1 year

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (8)

ASST Lariana, Ospedale Sant' Anna

San Fermo della Battaglia, Como, 22020, Italy

Location

ASST Nord Milano, Presidio Ospedaliero Bassini

Cinisello Balsamo, Milano, 20092, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

ASST Monza, Ospedale di Desio

Desio, Monza E Brianza, 20832, Italy

Location

ASST Lecco, Presidio Ospedaliero Alessandro Manzoni

Lecco, 23900, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

ASST Monza

Monza, 20900, Italy

Location

ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Study Officials

• Renato A Sinico, MD

  Università degli Studi di Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: November 15, 2021
• Study Start: July 15, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

IT (8)