Phase III Randomised Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 13
- 主要终点
- Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
研究概览
简要总结
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.
详细描述
Solitary bone plasmacytoma (SBP) is a localised proliferation of malignant plasma cells (PCs) in the skeleton. The annual UK incidence is 0.4/100,000 (lower than multiple myeloma (MM)) with a peak age incidence at 68 years and there are estimated to be about 260 new cases per year in the United Kingdom (UK). The majority of patients with SBP ultimately progress to myeloma and this is likely due to occult disease not detected by conventional staging methods. Standard care for these patients is involved field radiotherapy (IFRT), but despite radical doses, two-thirds develop multiple myeloma at a median of 2 years, more so if there are high risk features.
The IDRIS Trial is a phase III study where the investigators hope to demonstrate that adjuvant lenalidomide + dexamethasone following IFRT prevents the development of multiple myeloma in patients with high risk solitary bone plasmacytoma. Whilst a proportion of solitary bone plasmacytoma is cured with IFRT, it is clear that the majority will progress to multiple myeloma. The investigators are seeking to prevent this outcome by using adjuvant therapy in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
No further treatment
No further treatment
干预措施: No further treatment (Other)
Lenalidomide + Dexamethasone
Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 & 22 Up to 9 cycles
干预措施: Lenalidomide (Drug)
Lenalidomide + Dexamethasone
Lenalidomide 25mg orally daily on days 1-21 Dexamethasone 20mg orally on days 1, 8, 15 & 22 Up to 9 cycles
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression-free survival (progression defined as development of myeloma or a new plasmacytoma outside the radiotherapy field)
时间窗: 3 years from date of randomisation
Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PSF time will be measured from date of randomisation until progression or death.
次要结局
- Overall survival(3 years from date of randomisation)
- Time to next treatment(At any time during the trial (up to 6 years after last patient registered))
- Response to treatment(Approximately 1 month after Lenalidomide and Dexamethasone treatment)
- Safety and toxicity of adjuvant lenalidomide + dexamethasone(During, and one month post treatment (total approximately 10 months))
- Surveillance for secondary malignancies(5 years following treatment with lenalidomide and dexamethasone)
- Treatment Compliance(9 months from beginning of treatment)