IDRIS
Research type
Research Study
Full title
Phase III randomised trial of immunomodulatory therapy in high risk solitary bone plasmacytoma
IRAS ID
179775
Contact name
Mark Phillips
Contact email
Sponsor organisation
University College London
Eudract number
2015-001355-76
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Solitary bone plasmacytoma (SBP) is a form of blood cancer, in which abnormal plasma cells collect at a single location in the skeleton. The standard treatment is radiotherapy, however around two-thirds of patients either relapse or go on to develop a more widespread version of the disease called myeloma.
Scientists now think these patients relapse because they already have very low levels of disease present in their bone marrow when their plasmacytoma is diagnosed. Using blood and bone marrow tests, they think they are able to identify patients who are most likely to relapse. The IDRIS study will investigate whether progression can be delayed or prevented by giving these patients further treatment with lenalidomide and dexamethasone after radiotherapy.
140 patients with newly-diagnosed SBP will be registered into the trial after radiotherapy. A bone marrow sample will be reviewed to check for 'high risk' features predictive of relapse. Patients with 'high risk' features will be randomised to have either lenalidomide and dexamethasone (group A1) or no further treatment (group A2). Patients with no 'high risk' features (group B) will also have no further treatment.
Lenalidomide and dexamethasone treatment consists of up to 9 cycles of treatment, each lasting 4 weeks. Both drugs are taken at home, by mouth, and patients will be seen at their outpatient clinic every four weeks until treatment is finished.
Patients on all arms will be followed up for at least 5 years. They will be seen every 3 months until 2 years post radiotherapy, every 6 months in years 3-5 and annually thereafter.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/0592
Date of REC Opinion
19 Apr 2016
REC opinion
Favourable Opinion