Monoclonal Gammopathy of Unknown SignificanceNCT02933021
Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)
An observational study of Monoclonal Gammopathy of Unknown Significance, run by RxCelerate Ltd at 9 sites in United Kingdom.
Trial summary
This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Unknown Significance
- What is being tested?
- Blood sample taken, Answering a lifestyle questionnaire and Follow-up phone call from researcher (two years after first visit)
- How many people
- 664 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Jul 2016to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit patients diagnosed with Monoclonal Gammopathy of Unknown Significance.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Heartlands Hospital
Birmingham, West Midlands
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
St James's Hospital
Leeds, West Yorkshire
Guy's and St. Thomas' Hospital
London, SE1 9RT
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Nottingham City Hospital
Nottingham
Royal Berkshire Hospital
Reading, Berkshire
Rotherham Hospital
Rotherham, S602UD
Torbay Hospital
Torquay, Devon
About this study
Official title: Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A Research Study to Investigate the Functional Consequences of Paraprotein Production in MGUS
This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).
Read the 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.
- Being tested
- Blood sample taken, Answering a lifestyle questionnaire, Follow-up phone call from researcher (two years after first visit)
- Keywords
- MGUS
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample takenOther
Answering a lifestyle questionnaireOther
Follow-up phone call from researcher (two years after first visit)Other
To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Nurse visit for blood sample, questionnaire and phone call Receives: Other: Blood sample taken; Other: Answering a lifestyle questionnaire; Other: Follow-up phone call from researcher (two years after first visit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years from study start
Secondary outcomes (1)
The number of conversions to multiple myeloma
Measured: 2 years after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startJul 2016
- Primary completion28 Feb 2019
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Unknown SignificanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- RxCelerate Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RxCelerate Limited
- Responsible party
- Sponsor
- Investigators
- Jill Reckless, Principal investigator, RxCelerate Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933021
- Sponsor's protocol ID
- HAF 01
- Other IDs
- 193751, 16/EE/0071
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A Research Study to Investigate the Functional Consequences of Paraprotein Production in MGUS
- ClinicalTrials.gov ID
- NCT02933021
- Acronym / sponsor ID
- HAF 01
- Keywords
- MGUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 664 participants (actual)
- Lead sponsor
- RxCelerate LtdIndustry (pharma, biotech, devices)
- Collaborators
- RxCelerate Limited
- Study start
- Jul 2016
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: Blood sample taken, Other: Answering a lifestyle questionnaire, Other: Follow-up phone call from researcher (two years after first visit)Nurse visit for blood sample, questionnaire and phone call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit patients diagnosed with Monoclonal Gammopathy of Unknown Significance.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample taken | Other | All participants |
| Answering a lifestyle questionnaire | Other | All participants |
| 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. | Other | All participants |
Primary outcome
Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges.
Time frame: 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.
1 secondary outcome
The number of conversions to multiple myeloma
Time frame: 2 years after the first visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Reckless principal investigator
RxCelerate Limited
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathy of Unknown Significance, run by RxCelerate Ltd at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges. (time frame: Up to 4 years from study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.