Monoclonal Gammopathy of Unknown Significance
Conditions
Keywords
MGUS
Brief summary
This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).
Detailed description
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.
Interventions
OTHERBlood sample taken
OTHERAnswering a lifestyle questionnaire
OTHERFollow-up phone call from researcher (two years after first visit)
To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.
Sponsors
RxCelerate Limited
RxCelerate Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| The number of conversions to multiple myeloma | 2 years after the first visit |
Countries
United Kingdom
Outcome results
None listed