Unravel MGUS
Research type
Research Study
Full title
Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A research study to investigate the functional consequences of paraprotein production in MGUS
IRAS ID
193751
Contact name
Jill Reckless
Contact email
Sponsor organisation
Human Antibody Factory (HAF) Ltd.
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
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 primary objective of this study is estimate the prevalence of paraproteins binding to self antigen which cause a phenotype, survey the effects that these have and how they contribute to patient morbidity. Secondary objectives are to assess factors which may affect conversion to multiple myeloma (MM) and identify novel biological pathways causing the phenotypes observed.
The study will recruit patients diagnosed with MGUS. Identification will be performed by collaborating haematologists at a number of hospitals throughout the UK. At a routine clinical appointment, verbal consent will be obtained by the haematologist for a nurse from the Unravel MGUS team to contact the patient and a patient information sheet will be provided. Within 1-2 weeks the nurse will contact the patient and, if they are still willing to consider participating, a convenient appointment made for the nurse to visit them either at home, or if appropriate, at their work place. At this appointment, written informed consent will be obtained, a questionnaire administered and a blood sample obtained.
A large number of analyses will be performed on the blood samples obtained. Many of these will be clinical analyses aimed at investigating diseases of different organ systems. Others will be research tests.
Two years following collection of this blood sample, each participant will be re-contacted by telephone to enquire about the status of their MGUS and whether there has been progression to MM.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0071
Date of REC Opinion
19 May 2016
REC opinion
Further Information Favourable Opinion