MGRS: Clinical-histological Features of a Multicenter Case Series
Condition: Monoclonal Gammopathy of Renal Significance
MeSH terms: Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Retrospective
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.
      
Keywords: MGRS