Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
IDRIS
Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
1 other identifier
interventional
36
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2017
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedDecember 23, 2022
December 1, 2022
9.1 years
July 28, 2015
December 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years from date of randomisation
Secondary Outcomes (6)
Overall survival
3 years from date of randomisation
Time to next treatment
At any time during the trial (up to 6 years after last patient registered)
Response to treatment
Approximately 1 month after Lenalidomide and Dexamethasone treatment
Safety and toxicity of adjuvant lenalidomide + dexamethasone
During, and one month post treatment (total approximately 10 months)
Surveillance for secondary malignancies
5 years following treatment with lenalidomide and dexamethasone
- +1 more secondary outcomes
Study Arms (2)
No further treatment
ACTIVE COMPARATORNo further treatment
Lenalidomide + Dexamethasone
EXPERIMENTALLenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 \& 22 Up to 9 cycles
Interventions
Eligibility Criteria
You may qualify if:
- Patients with newly-diagnosed SBP
- 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
You may not qualify if:
- Multifocal plasmacytoma, solitary extramedullary plasmacytoma or myeloma
- ≥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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Cancer Research UKcollaborator
- Celgenecollaborator
Study Sites (13)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Owen
St James's University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2015
First Posted
September 9, 2015
Study Start
March 10, 2017
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 23, 2022
Record last verified: 2022-12