Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

  • STATUS
    Recruiting
  • End date
    Jun 2, 2023
  • participants needed
    27
  • sponsor
    Columbia University
Updated on 2 December 2021

Summary

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means that the use of isatuximab in this study is considered 'investigational'.

Description

Monoclonal gammopathy is a common disorder but only a small fraction of patients with monoclonal gammopathy of undetermined significance (MGUS) develop renal disease and the reason for abnormal deposition of immunoglobulin in renal parenchyma remains unclear in these disorders. The proposed research will be conducted as a part of clinical trial which intends to prospectively evaluate the effect of anti-plasma cell therapy on renal outcomes in patients with monoclonal gammopathy of renal significance (MGRS). The study specifically intends to sequence the immunoglobulin heavy and light chain genes to determine any abnormalities that could lead to production of a misfolded immunoglobulin thus leading to deposition in renal parenchyma.

Details
Condition monoclonal gammopathies, Monoclonal Gammopathy of Undetermined Significance, Monoclonal gammopathy
Treatment Isatuximab
Clinical Study IdentifierNCT04614558
SponsorColumbia University
Last Modified on2 December 2021

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