The purpose of the trial is to establish whether adjuvant therapy with lenalidomide + dexamethasone after radiotherapy can improve progression free survival in patients with high risk solitary bone plasmacytoma compared with RT only.
Solitary bone plasmacytoma (SBP) is a localised proliferation of malignant plasma cells (PCs) in the skeleton. The annual UK incidence is 0.4/100,000 (lower than multiple myeloma (MM)) with a peak age incidence at 68 years and there are estimated to be about 260 new cases per year in the United Kingdom (UK). The majority of patients with SBP ultimately progress to myeloma and this is likely due to occult disease not detected by conventional staging methods. Standard care for these patients is involved field radiotherapy (IFRT), but despite radical doses, two-thirds develop multiple myeloma at a median of 2 years, more so if there are high risk features. The IDRIS Trial is a phase III study where the investigators hope to demonstrate that adjuvant lenalidomide + dexamethasone following IFRT prevents the development of multiple myeloma in patients with high risk solitary bone plasmacytoma. Whilst a proportion of solitary bone plasmacytoma is cured with IFRT, it is clear that the majority will progress to multiple myeloma. The investigators are seeking to prevent this outcome by using adjuvant therapy in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Experimental Arm
Experimental Arm
Comparator Arm
Royal United Hospital
Bath, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
University Hospital Wales
Cardiff, United Kingdom
Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PSF time will be measured from date of randomisation until progression or death.
Time frame: 3 years from date of randomisation
Overall survival
Time from randomisation to death of any cause will be compared between arms
Time frame: 3 years from date of randomisation
Time to next treatment
The time from end of radiotherapy to first date of any non-protocol treatment for plasmacytoma or myeloma will be compared between arms
Time frame: At any time during the trial (up to 6 years after last patient registered)
Response to treatment
The number and proportion of patients on the lenalidomide + dexamethasone arm who achieve normalisation of the SFLCr and/or the disappearance of aberrant plasma cell phenotype following Lenalidomide + Dexamethasone treatment will be documented.
Time frame: Approximately 1 month after Lenalidomide and Dexamethasone treatment
Safety and toxicity of adjuvant lenalidomide + dexamethasone
During treatment and follow up, the frequency and percentages of adverse events with a maximum severity of grade 3-5 (according to CTCAE v4.03) will be collected.
Time frame: During, and one month post treatment (total approximately 10 months)
Surveillance for secondary malignancies
Second primary malignancies occurring during treatment and in the 5 years after treatment will be recorded in patients on the lenalidomide + dexamethasone arm
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Velindre Cancer Centre
Cardiff, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James University Hospital
Leeds, United Kingdom
University College London Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Mount Vernon Cancer Centre
Northwood, United Kingdom
...and 3 more locations
Time frame: 5 years following treatment with lenalidomide and dexamethasone
Treatment Compliance
Compliance with lenalidomide and dexamethasone treatment will be assessed using descriptive statistics. The number of reductions, delays and omissions of lenalidomide and dexamethasone will be presented as well as the median time on study treatment
Time frame: 9 months from beginning of treatment