EUCTR2015-001355-76-GB
Active, not recruiting
Phase 1
Phase III randomised trial of immunomodulatory therapy in high risk solitary bone plasmacytoma - IDRIS
niversity College London0 sites140 target enrollmentMarch 31, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Not specified
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