BLOOM: Blood markers in multiple myeloma v1.0
Research type
Research Study
Full title
Improving the monitoring and treatment of multiple myeloma patients by comparing cellular and serological markers of minimal residual disease.
IRAS ID
252000
Contact name
Lauren Campbell
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Multiple myeloma is a cancer in the bone marrow. In the UK 5,500 new patients are identified with multiple myeloma each year. Patients are given treatment such as chemotherapy and many will also be given a stem cell transplant to replace the cancer cells in the bone marrow with healthy cells. After treatment patients have very few cancer cells left. However, the number of cancer cells in the bone marrow may start to increase again. It is important to detect these cells as soon as possible to allow for new treatment to begin. Very sensitive tests are needed to detect these low numbers of cancer cells. One current test involves taking a bone marrow sample. However, having bone marrow samples taken is painful and unpleasant.
This study will investigate whether two new blood tests can replace the bone marrow test. We will compare the results of bone marrow and blood tests performed at the same time. We will also follow up participants with regular blood tests to see whether we can detect a return of the disease quicker than current methods. This study will take place over 3 years within the NHS and will include newly diagnosed multiple myeloma patients and those with a condition which often occurs before the development of multiple myeloma (smouldering multiple myeloma).
The planned sample size is 231 participants who will be split into 3 groups. Group 1 (108 participants) are those with multiple myeloma who are eligible for a stem cell transplant. Group 2 (98 participants) are those with multiple myeloma who are ineligible for a stem cell transplant. Group 3 (25 participants) are those who have been diagnosed with smouldering multiple myeloma. Patients will only give extra samples when these are already being taken as part of their usual care.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0025
Date of REC Opinion
7 Jan 2019
REC opinion
Favourable Opinion