A trial testing lenalidomide and dexamethasone after standard radiotherapy in patients with solitary bone plasmacytoma who are at a high risk of relapse

Phase 1

• Conditions: Solitary bone plasmacytoma; MedDRA version: 21.1Level: PTClassification code 10035484Term: PlasmacytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001355-76-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-31
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

INCLUSION CRITERIA FOR REGISTRATION:
1. Patients with newly-diagnosed SBP as defined by IMWG and BCSH guidelines that has been confirmed histologically
2. Treated or being treated with local radiotherapy as per BCSH guidelines
3. Age =18 years
4. ECOG performance status 0-2
5. Written informed consent
6. Willing to comply with the requirements of the Celgene pregnancy prevention programme

INCLUSION CRITERIA FOR RANDOMISATION:
1. Patients who have one or both of the high risk features will be eligible for randomisation:
- Phenotypically aberrant plasma cells in a BM aspirate taken from a site outside the radiotherapy field and/or
- Abnormal serum free light chain ratio at diagnosis or the next possible time point if not collected at diagnosis (determined by local reference ranges)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

EXCLUSION CRITERIA FOR REGISTRATION:
1. Multifocal plasmacytoma, solitary extramedullary plasmacytoma or myeloma
2. =10% bone marrow plasma cells
3. On, or planned for, systemic steroid therapy (e.g. dexamethasone or prednisolone) unless otherwise agreed by the TMG
4. Severe hepatic impairment (bilirubin >2xULN or AST/ALT >2xULN)
5. Creatinine clearance <30mL/min
6. Pregnant or lactating women
7. Non-haematological malignancy within the past 3 years (exceptions apply – see section 6.2.2)
8. Patients at a high risk of venous thromboembolism due to:
-Treatment with erythropoietic stimulating agents (e.g. erythropoetin, epoetin alpha, neo- recormon, aranesp)
-Other risk factors not listed above
9. Patients with untreated osteoporosis
10. Patients with uncontrolled diabetes
11. Patients with glaucoma
12. Any other medical or psychiatric condition likely to interfere with study participation
13. 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 within 4 weeks of planned start of lenalidomide and dexamethasone.
14. Evidence of current or past hepatitis B infection.
15. Uncontrolled active systemic infection.

EXCLUSION CRITERIA FOR RANDOMISATION:
1. Receiving or intention to treat with systemic corticosteroid therapy (e.g. Dexamethasone) unless otherwise agreed by the TMG.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified