Clinical trial · Interventional
Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
NCT02544308CI-TRIAL-00062865IDRISactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plasmacytoma | Plasmacytoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| No further treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- No further treatment
- description
- No further treatment
- interventionNames
- Other: No further treatment
- type
- EXPERIMENTAL
- label
- Lenalidomide + Dexamethasone
- description
- Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 \& 22 Up to 9 cycles
- interventionNames
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. 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)
References
Publications (0)
Data not yet available
No reference posted for this study.