After we have confirmed your eligibility for the study we will carry out some initial study assessments:
- Record your height & weight
- Take blood samples to be sent to the hospital laboratory for standard tests. A urine sample is also needed for participants with MGUS, WM or SM.
- Take blood samples to be sent to specialist research laboratories for research tests.
- For individuals with MBL, Stage A CLL and WM, a saliva sample will be taken (using spit); for participants with MGUS or SM, we will use a peripheral blood sample instead.
- Ask you to fill-in some quality of life questionnaires
Either on the same day or within the next 8 weeks you will also have:
- A bone marrow biopsy to take a sample of liquid (aspirate) from your bone marrow
- Imaging: a CT scan or MRI scan. If you’ve been diagnosed with IgG MGUS, IgA MGUS or smouldering myeloma you’ll have an MRI scan. All other participants will have a CT scan.
You might already have had a CT, PET-CT or MRI scan as part of your routine care, particularly if you have been diagnosed with SM or MGUS. If this is the case and the previous scan was in the last year we will ask for a copy of the report from the previous scan instead of (or as well as) you having a further scan. If you’ve already had a scan but we ask you to have another this will always be an MRI. This is to limit the amount of radiation you are exposed to as MRIs (unlike CT and PET-CT) do not expose you to radiation.
More specific detail about the bone marrow aspirate, scans and other research assessments can be found in our participant information sheet.
After the first visit we would like to see you again around 2 years later and 5 years later. We will also contact you by phone after 1 year to confirm you’re still happy to be involved and answer any questions you have. The visits at year 2 and year 5 will consist of:
- A physical examination
- Blood samples
- Urine sample (participants with MGUS, WM or SM only)
- Completion of quality of life questionnaires
- Asking you about any significant new medical conditions since your last visit and any new medications you’re taking
If your condition is found to progress over the course of the study you will be invited for a further bone marrow biopsy and scan.
After the year 5 visit your involvement in the study will be over. Please note that if you are one of the later participants to join the study you may not have a year 5 visit, as the study may end before you have taken part for 5 years. If this is the case we will write to you to let you know that you no longer need to attend any study visits.