Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

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

Detailed Description
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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.

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

Conditions
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Monoclonal Gammopathy of Unknown Significance

Intervention / Treatment
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* Other: Blood sample taken
* Other: Answering a lifestyle questionnaire
* Other: Follow-up phone call from researcher (two years after first visit)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Nurse visit for blood sample, questionnaire and phone call | Other: Blood sample taken<br> <br> Other: Answering a lifestyle questionnaire<br> <br> Other: Follow-up phone call from researcher (two years after first visit)<br>* To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges. | 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. | Up to 4 years from study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of conversions to multiple myeloma |  | 2 years after the first visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MGUS