Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

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

This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).

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.

Inclusion Criteria:

Participants must comply with the following criteria in order to be eligible for the study:

• Be aged ≥18 years at the time the informed consent form is signed
• Have a confirmed and documented Monoclonal Gammopathy of Unknown Significance (MGUS) diagnosis
• Read and understood the participant information sheet, and signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form prior to any study- specific evaluation

Exclusion Criteria:

Participants will be excluded from joining the study if they match any of the criteria below:

• Pre-existing diagnosis of myeloma/lymphoma
• Participation in a therapeutic clinical study within 28 days or (5 half lives, whichever is longer) of enrolment or during this study
• Any other reason the Clinical Investigator (CI) considers the participant should not join the study