Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
Cancer Research UK
Chief Investigator:
Dr Roger Owen
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Phase III randomised trial of immunomodulatory therapy in high risk solitary bone plasmacytoma
Design: IDRIS is a multicentre randomised phase III study investigating whether a combination of lenalidomide and dexamethasone can delay or prevent disease progression in patients with newly-diagnosed solitary bone plasmacytoma, treated with standard radiotherapy, whose disease has features predicting a high risk of developing multiple myeloma. 
Treatment: Following study entry, patients will have a bone marrow biopsy to test for the presence of abnormal plasma cells. Their serum free light chain ratio will also be measured to see if it is abnormal. Patients with one or more ‘high risk’ features are randomised with a 1:1 ratio to receive either lenalidomide and dexamethasone or no further treatment. Patients randomised to receive trial treatment will have up to 9 four-week cycles of oral lenalidomide and dexamethasone (lenalidomide days 1-21, dexamethasone weekly). Patients randomised to no treatment, and patients without high risk features, will have regular follow up. All patients on the trial will be followed up for at least 5 years, with regular quality of life assessments for the first two years.
Key inclusion/exclusion criteria: Patients aged 18 or over with newly-diagnosed solitary bone plasmacytoma that has been treated with local radiotherapy in the past 28 days, with a good response. Patients must have a performance status of 0-2, have adequate liver and kidney function and cannot have glaucoma, uncontrolled diabetes, untreated osteoporosis or a high risk of thrombosis. Patients cannot be pregnant or lactating and must agree to comply with the Celgene Pregnancy Prevention Programme.
Duration of recruitment: 4 years
To establish whether adjuvant therapy with lenalidomide and dexamethasone after radiotherapy can improve progression free survival (delaying either development of a new plasmacytoma or progression to multiple myeloma) in patients with high risk solitary bone plasmacytoma compared to radiotherapy only. The study will also investigate the safety and tolerability of lenalidomide and dexamethasone, whether lenalidomide and dexamethasone can eradicate high risk features such as an abnormal serum free light chain ratio or abnormal plasma cells, and explore the impact of the two approaches used on patients’ quality of life.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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