Control Samples For Multiple Myeloma Patient Trials (CSMPT)
Research type
Research Study
Full title
Defining baseline immune characteristics in unaffected populations as comparators for UK myeloma trial samples
IRAS ID
267072
Contact name
Jonathan Carmichael
Contact email
Duration of Study in the UK
0 years, 4 months, 21 days
Research summary
Multiple myeloma (MM) is a bone marrow cancer responsible for damage to the kidneys, bones and immune system of the affected patient. Leeds myeloma practice is at the forefront of new and emerging treatments, including using the patient's own immune system (immunotherapy) to combat the disease. The capability of each individual's immune system to respond to stimulation is highly variable and declines with age and this has implications for how effective immunotherapy may be. When looking for characteristic changes in immune aptitude in myeloma patients, it is therefore critical to have a comparative population of healthy controls of a similar, age, sex and ethnicity.
This single-centre study in Leeds aims to collect a single 20ml blood sample patients with monoclonal gammopathy of undetermined significance (MGUS), the precursor state to multiple myeloma and 20 or 70mls of blood from healthy controls . We will then use modern techniques, including genetic analysis, to systematically examine the diversity and competence of the immune system, comparing the results to those obtained in multiple myeloma trial patients (covered under separate ethical approval). We hypothesise that certain immune characteristics may help us to predict those patients less likely to tolerate treatment, those at particular risk of life-threatening side effects and those most likely to benefit from immunotherapy.
The majority of healthy controls will have 20mls of blood taken. In those patients who are suitable for and consent to additional samples an extra 50mls will be taken. This additional blood will be used to analyse the effects of changes in storage conditions on the results obtained. This is to mimic the conditions that the clinical trial samples are exposed to when they are transported from across the country to the experimental laboratory.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0242
Date of REC Opinion
25 Feb 2020
REC opinion
Favourable Opinion