A Prospective Long-term Observational Study in Patients With Monoclonal Gammopathy of Undetermined Significance

NCT05539079 | Recruiting DMC

• 1 other identifier: PID15967
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Myeloma (MM) is a rare blood cancer affecting over 5000 people a year in the UK. All cases of myeloma start with a condition called monoclonal gammopathy of undetermined significance (MGUS). MGUS occurs in approximately 3.2% of people aged 50 and over. Only a small proportion of these people - around 1% each year - will develop myeloma. Most people with MGUS have no symptoms, but a small number of people will suffer complications. This group are referred to as having monoclonal gammopathy of clinical significance (MGCS). People with myeloma frequently experience long delays in diagnosis; the delays are longer than for any other cancer. Although we know that MGUS leads to myeloma, most cases of MGUS are only found 'incidentally' when the person is having blood tests for something else. And the people who have MGUS do not have consistent testing or follow up. This situation means that 80 - 90% of people who are diagnosed with myeloma did not have an earlier MGUS diagnosis. Earlier diagnosis of myeloma might be possible with better understanding MGUS and how it should be monitored. The SECURE study will help with this. It will help confirm the rate at which people with MGUS progress to a diagnosis of myeloma. It will further understanding of screening, diagnosis, and monitoring patterns of people with MGUS and MGCS in the UK. The study aims to find out more about the role of family history and demographic factors in the development of MGUS. It will also find out more about the psychological impact of an MGUS diagnosis and individual quality of life. Patients with MGUS will be identified by their clinical care team and invited to participate in the SECURE study. Participants will be required to answer surveys and questionnaires annually for a period of 5 years or until their disease changes. The study will recruit participants from 20 NHS sites in the UK. Some will be asked to provide blood samples. SECURE is funded by Cancer Research UK (CRUK) and the National Institute for Health Research (NIHR).

Conditions

MGUS

Outcome Measures

Primary Outcomes (1)

• Progression rate to MM

  Progression rate to MM during observation

  Through study completion, assessed up to 60 months

Secondary Outcomes (8)

• MGUS monitoring patterns as determined via questionnaire

  Through study completion, an average of 5 years

• MGCS screening as determined via questionnaire

  Through study completion, an average of 5 years

• Understanding routes to MGUS diagnosis as determined via questionnaire

  Baseline

• To understand family linkage in relation to MGUS as determined via questionnaire

  Baseline

• Quality of Life measured by the EQ-5D-3L Questionnaire

  Through study completion, an average of 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be those with a diagnosis of Monoclonal gammopathy. Patients who are suitable for the study will be identified by the treating haemato-oncology clinician, the clinical nurse specialist, the myeloma service coordinators and at the local multidisciplinary team (MDT) meetings in the participating hospitals.

You may qualify if:

• Any individual with a confirmed or suspected case of MGUS

You may not qualify if:

• Those who are unable or unwilling to give informed consent
• Patients under the age of 18
• Patients with no evidence of MGUS
• Patients with a light chain ratio of 0.3 to 3.0 without a monoclonal protein on serum electrophoresis or immunofixation

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Secure Study

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

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Related Links

• Cancer statistics
• Myeloma survival rates

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• Karthik Ramasamy

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Brouwer, BSc

CONTACT

07594301699; richard.brouwer@ouh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 14, 2022
• Study Start: September 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2032
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

GB (1)