Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
NCT ID: NCT02544308
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
36 participants
INTERVENTIONAL
2017-03-10
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No further treatment
No further treatment
No further treatment
Comparator Arm
Lenalidomide + Dexamethasone
Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 \& 22 Up to 9 cycles
Lenalidomide
Experimental Arm
Dexamethasone
Experimental Arm
Interventions
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Lenalidomide
Experimental Arm
Dexamethasone
Experimental Arm
No further treatment
Comparator Arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* SBP treated with local radiotherapy with curative intent (see appendix 2).
* Radiotherapy completed within 28 days of registration
* Age ≥18 years
* ECOG performance status 0-2
* Written informed consent
* Willing to comply with the requirements of the Celgene pregnancy prevention programme
Exclusion Criteria
* ≥10% bone marrow plasma cells
* Clinical suspicion of failure to respond to radiotherapy
* Receiving or intention to treat with systemic corticosteroid therapy (e.g. dexamethasone or prednisolone) unless otherwise agreed by the TMG
* Severe hepatic impairment (bilirubin \>2xULN or AST/ALT \>2xULN)
* Creatinine clearance \< 30 mL/min
* Pregnant or lactating women
* Non-haematological malignancy within the past 3 years (exceptions apply - see section 6.2.2)
* Patients at a high risk of venous thromboembolism due to:
* Treatment with erythropoietic stimulating agents (e.g. erythropoietin, epoetin alpha, epoetin beta, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta)
* Other risk factors not listed above and unable to receive thromboprophylaxis
* Patients with untreated osteoporosis
* Patients with uncontrolled diabetes
* Patients with a known history of glaucoma
* Any other medical or psychiatric condition likely to interfere with study participation
* Receiving treatment with an experimental drug or experimental medical device. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. Any experimental drug treatments must be stopped at least 4 weeks before planned start of lenalidomide and dexamethasone.
* Evidence of current or past hepatitis B infection. Patient should test negative for both surface antigen (HBsAg) and hepatitis B core antibody (HBcAb)
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Celgene
INDUSTRY
University College, London
OTHER
Responsible Party
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Principal Investigators
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Roger Owen
Role: PRINCIPAL_INVESTIGATOR
St James's University Hospital
Locations
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Royal United Hospital
Bath, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
University Hospital Wales
Cardiff, , United Kingdom
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
Royal Preston Hospital
Preston, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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UCL/13/0291
Identifier Type: -
Identifier Source: org_study_id