Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

RxCelerate Ltd664 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

664

Conditions

Monoclonal Gammopathy of Unknown Significance

Interventions

Blood sample takenOTHER

Answering a lifestyle questionnaireOTHER

Follow-up phone call from researcher (two years after first visit)OTHER

To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Royal Berkshire Hospital

Reading, Berkshire, United Kingdom

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

Torbay Hospital

Torquay, Devon, United Kingdom

Heartlands Hospital

Birmingham, West Midlands, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Up to 4 years from study start

Secondary Outcomes

The number of conversions to multiple myeloma

Time frame: 2 years after the first visit

Data from ClinicalTrials.gov

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