Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

RxCelerate

Status: Unknown

Conditions: Monoclonal Gammopathy of Unknown Significance

Treatments: Other: Blood sample taken; Other: Follow-up phone call from researcher (two years after first visit); Other: Answering a lifestyle questionnaire

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02933021

16/EE/0071 (Other Identifier)

HAF 01

193751 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 664 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

664 participants in 1 patient group

All participants

Description:

Nurse visit for blood sample, questionnaire and phone call

Treatment:

Other: Answering a lifestyle questionnaire

Other: Follow-up phone call from researcher (two years after first visit)

Other: Blood sample taken