Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)
Study Details
Study Description
Brief Summary
This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All participants Nurse visit for blood sample, questionnaire and phone call |
Other: Blood sample taken
Other: Answering a lifestyle questionnaire
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- The number of conversions to multiple myeloma [2 years after the first visit]
Eligibility Criteria
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:
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Pre-existing diagnosis of myeloma/lymphoma
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Participation in a therapeutic clinical study within 28 days or (5 half lives, whichever is longer) of enrolment or during this study
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Any other reason the Clinical Investigator (CI) considers the participant should not join the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Berkshire Hospital | Reading | Berkshire | United Kingdom | |
| 2 | Addenbrookes Hospital | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
| 3 | Torbay Hospital | Torquay | Devon | United Kingdom | |
| 4 | Heartlands Hospital | Birmingham | West Midlands | United Kingdom | |
| 5 | St James's Hospital | Leeds | West Yorkshire | United Kingdom | |
| 6 | Guy's and St. Thomas' Hospital | London | United Kingdom | SE1 9RT | |
| 7 | Freeman Hospital | Newcastle upon Tyne | United Kingdom | NE7 7DN | |
| 8 | Nottingham City Hospital | Nottingham | United Kingdom | ||
| 9 | Rotherham Hospital | Rotherham | United Kingdom | S602UD |
Sponsors and Collaborators
- RxCelerate Ltd
- RxCelerate Limited
Investigators
- Principal Investigator: Jill Reckless, RxCelerate Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HAF 01
- 193751
- 16/EE/0071