Clinical trial NCT02933021: Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)
Official title: Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A Research Study to Investigate the Functional Consequences of Paraprotein Production in MGUS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Monoclonal Gammopathy of Unknown Significance
Keywords: MGUS
Lead sponsor: RxCelerate Ltd
Sponsor class: INDUSTRY
Collaborators: name: RxCelerate Limited
First posted: 2016-10-14
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit patients diagnosed with Monoclonal Gammopathy of Unknown Significance.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges.
timeFrame: Up to 4 years from study start
Secondary outcomes:
measure: The number of conversions to multiple myeloma
timeFrame: 2 years after the first visit
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
state: Berkshire
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Torquay
country: United Kingdom
facility: Torbay Hospital
state: Devon
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
state: West Midlands
city: Leeds
country: United Kingdom
facility: St James's Hospital
state: West Yorkshire
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Rotherham
country: United Kingdom
facility: Rotherham Hospital
Study officials:
affiliation: RxCelerate Limited
name: Jill Reckless
role: PRINCIPAL_INVESTIGATOR
References: