Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

• Conditions: Monoclonal Gammopathy of Unknown Significance

• Registration Number: NCT02933021
• Lead Sponsor: RxCelerate Ltd

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Primary Completion: 2019-02-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The number of conversions to multiple myeloma	2 years after the first visit

Trial Locations

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

St James's Hospital; 🇬🇧 Leeds, West Yorkshire, United Kingdom

Guy's and St. Thomas' Hospital; 🇬🇧 London, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom

Nottingham City Hospital; 🇬🇧 Nottingham, United Kingdom

Rotherham Hospital; 🇬🇧 Rotherham, United Kingdom