NCT02933021

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

September 15, 2016

Last Update Submit

September 1, 2020

Conditions

Monoclonal Gammopathy of Unknown Significance

Keywords

MGUS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The number of conversions to multiple myeloma

    2 years after the first visit

Study Arms (1)

All participants

Nurse visit for blood sample, questionnaire and phone call

Other: Blood sample takenOther: Answering a lifestyle questionnaireOther: Follow-up phone call from researcher (two years after first visit)

Interventions

Blood sample takenOTHER
All participants
Answering a lifestyle questionnaireOTHER
All participants
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.

All participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will recruit patients diagnosed with Monoclonal Gammopathy of Unknown Significance.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Royal Berkshire Hospital

Reading, Berkshire, United Kingdom

Location

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Torbay Hospital

Torquay, Devon, United Kingdom

Location

Heartlands Hospital

Birmingham, West Midlands, United Kingdom

Location

St James's Hospital

Leeds, West Yorkshire, United Kingdom

Location

Guy's and St. Thomas' Hospital

London, SE1 9RT, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham City Hospital

Nottingham, United Kingdom

Location

Rotherham Hospital

Rotherham, S602UD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

HypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesParaproteinemiasImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jill Reckless

    RxCelerate Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

October 14, 2016

Study Start

July 1, 2016

Primary Completion

February 28, 2019

Study Completion

February 28, 2021

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(9)