LOOMIS- myeLOma bOne MrI Study
Research type
Research Study
Full title
The development and pilot testing of a new Magnetic Resonance (MR) imaging protocol to quantify both myeloma disease burden and associated bone loss.
IRAS ID
227800
Contact name
Karthik Ramasamy
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
Research Summary
Multiple myeloma, a malignancy of monoclonal B-cells, is the second most common haematological malignancy, compromising of 2% of all cancers in the UK and is currently incurable. In order to assess responses to treatment and relapses accurately, and to evaluate new therapeutics, changes in disease burden must be quantified over time. However, the extent of lytic bone disease, the major cause of injury in myeloma affecting over 90% of patients, still cannot be quantified. The Myeloma Bone MRI study aims to address this important and unmet clinical need by piloting a novel combined MR (Magnetic Resonance) imaging assessment of disease burden and bone loss in myeloma.60 participants are expected to be recruited from one site (Churchill Hospital, Oxford) over two years. These participants will include myeloma patients (Group 1), MGUS- monoclonal gammopathy of uncertain significance patients (Group 2) and healthy volunteers (Group 3). Participants consenting to take part in the study will be assessed to confirm their eligibility for the study. Eligible participants will undergo the experimental combined MR imaging protocol. Group 1 and 2 participants only (not Group 3) will undergo a DXA imaging scan, blood and urine tests done within 4 weeks of the MR appointment.
Participants in Groups 1 and 2 will undergo a further experimental MR scan, DXA imaging scan, blood and urine tests at 6 months, or progression/relapse, whichever is sooner (but no sooner than 3 months after baseline investigations) to evaluate changes in disease burden and bone loss.Groups 1 and 2 participants will also complete a validated quality of life questionnaire at baseline and at 6 months to assess patient reported outcome measures. Participants in Groups 1 and 2 will also be asked to complete a short questionnaire relating to the MRI and DXA imaging at baseline and 6 months for assessment of patient experiences of both imaging procedures, before and after treatment.
Summary of Results
Although myeloma is incurable, there are a growing range of treatments available to reduce tumour size and bone disease.However, there is currently a lack of adequate tools that can measure disease extent, so it can be difficult to know who would benefit from therapy and to track response. In LOOMIS, we piloted the use of a novel Magnetic Resonance (MR) protocol, and blood markers of bone health, to assess tumour burden and associated bone disease. We tested these tools in a wide patient population, including healthy volunteers, those with the precursor state to myeloma (MGUS), new and relapsed myeloma, to test their clinical value when added to standard clinical assessment.
The study recruited 69 participants over a two-year period (between March 2018 and March 2020). At enrolment, all participants were invited to have the novel MR scan and completed a questionnaire to understand their experience; those with myeloma and MGUS additionally had a standard NHS scan of bone health (DEXA) and blood tests taken to measure markers of bone health. Whilst this assessment was a one-off for healthy volunteers, those with myeloma and MGUS were invited to have a repeat follow-up assessment at 6 months, to assess how these tools detected changes in disease.
We found that one bone marker (DKK1) was associated with tumour extent, and another (sclerostin) with bone health. Furthermore, assessment of paired novel MR scans between baseline and follow-up could detect therapy response in agreement with standard clinical tools. Patient experience of the novel MR protocol was acceptable.Collectively, these results suggest possible imaging and bone markers that may be used to measure myeloma tumour burden and bone health, helping the clinician to assess disease more fully and match treatments to patients who need them more effectively.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0046
Date of REC Opinion
5 Feb 2018
REC opinion
Favourable Opinion