Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma

• Status: Active, not recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborators: Cancer Research UK; Celgene
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide

Criteria

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)