Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma (NCT02544308) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
United Kingdom36 participantsStarted 2017-03-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Receiving treatment with an experimental drug or experimental medical device…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)