Clinical Trial: Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A Research Study to Investigate the Functional Consequences of Paraprotein Production in MGUS

Brief Summary: This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal gammopathy of unknown significance).

Detailed Summary:

Monoclonal gammopathy of unknown significance (MGUS) is a common haematological condition. It is characterised by proliferation of a B lymphocyte clone and it's associated antibody (paraprotein). In most cases there are no clinical symptoms, however, in a small number of individuals there may be an interaction of the paraprotein with a molecule expressed by the body (self antigen). This can have effects on the normal function of this molecule and/or cause disease.

The study aims to investigate the functional consequences of paraprotein production in MGUS.


Sponsor: Human Antibody Factory Limited

Current Primary Outcome:

  • Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges. [ Time Frame: Up to 4 years from study start ]
    For clinical assays with defined normal ranges, we will capture those results that are significantly outside of normal range. For those with no generally accepted normal ranges, the results will be compared against results from the other individuals.
  • Quantitative analysis of cytokine/chemokines, measured by multiplex immunoassays . [ Time Frame: Up to 4 years from study start ]
    The results will be compared against results from the other individuals.
  • Metabolic profile of metabolites in blood measured by gas chromatography-mass spectrometry and nuclear magnetic resonance spectrometry. [ Time Frame: Up to 4 years from study start ]
    the data points and over all profiles will be compared against results from the other individuals.


Original Primary Outcome: Same as current

Current Secondary Outcome: The number of conversions to multiple myeloma [ Time Frame: Up to 4 years from study start ]

Original Secondary Outcome: Same as current

Information By: Human Antibody Factory Limited

Dates:
Date Received: September 15, 2016
Date Started: July 2016
Date Completion: September 2018
Last Updated: October 13, 2016
Last Verified: October 2016