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).
None
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
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.
Cohort
Prospective
Not listed
Progression rate to MM
Progression rate to MM during observation
MGUS monitoring patterns as determined via questionnaire
Qualitative analysis to determine the monitoring patterns of patients with MGUS and the rationale behind them
MGCS screening as determined via questionnaire
Qualitative analysis to determine the screening of patients with MGCS
Understanding routes to MGUS diagnosis as determined via questionnaire
Qualitative analysis to determine routes to MGUS diagnosis Screening vs Incidental
To understand family linkage in relation to MGUS as determined via questionnaire
To understand family linkage in relation to MGUS as determined via questionnaire
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