Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

Monoclonal Gammopathy of Unknown Significance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02933021
• Other study ID #: HAF 01
• Secondary ID: 19375116/EE/0071
• Status: Active, not recruiting
• Start date: July 2016
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2020
• Source: Human Antibody Factory Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 664
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Monoclonal Gammopathy of Unknown Significance
• Paraproteinemias

Intervention

Other:
• Blood sample taken

• Answering a lifestyle questionnaire

• Follow-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.

Locations

Country	Name	City	State
United Kingdom	Heartlands Hospital	Birmingham	West Midlands
United Kingdom	Addenbrookes Hospital	Cambridge	Cambridgeshire
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	Royal Berkshire Hospital	Reading	Berkshire
United Kingdom	Rotherham Hospital	Rotherham
United Kingdom	Torbay Hospital	Torquay	Devon

Sponsors (2)

Lead Sponsor	Collaborator
Human Antibody Factory Limited	RxCelerate Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of conversions to multiple myeloma		2 years after the first visit