ACTRN12612000338864已完成2 期
The effect of Pomalidomide compared to pomalidomide and dexamethasone on natural killer cells and disease response in Relapsed and Refractory Myeloma patients
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 80 人开始时间: 2012年3月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •At study entry:
- •Diagnosed with relapsed and refractory mutiple myeloma (MM) (diagnosis of MM as per International Myeloma Working Group (IMWG))
- •-Measurable M-component (monoclonal protein) in serum or urine,
- •-In patients with no detectable M-component, an abnormal Free light chain (FLC) ratio on the serum FLC assay
- •At least 2 prior therapies:
- •-Must include lenalidomide – failing to respond, disease progression during treatment or within 60 days of treatment completion (at least 2 cycles)
- •-May include autologous stem cell transplant (ASCT) (induction/ASCT/maintenance is one line of therapy).
- •Eastern Co-operative Oncology Group (ECOG) performance status 0-2
- •Adequate liver and kidney function (less than or equal to 2 x institutional upper limit of normal)
- •Haemoglobin (Hb) greater than or equal to 80g/L, Platelet count greater than or equal to 75 x 10^9, absolute neutrophil count greater than or equal to 1.0 x 10^9. Subjects who fail screening due to neutropenia or anaemia will not be permitted to use growth factors to become eligible.
- •No contraindication to the use of any of the study drugs
- •No concomitant steroids other than dexamethasone outlined in this protocol
- •Patient has voluntarily agreed and has given written informed consent.
- •Life expectancy of > 8 weeks
- •Patient must be greater than or equal to 4 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug
- •Patients to comply with lenalidomide Pregnancy Prevention Plan
- •Study site must be able to get correlative samples to the Alfred Hospital, Melbourne, within 24 hours of collection.
- •Prior to randomisation:
- •Have completed 4 cycles of induction therapy
- •Have no evidence of progressive MM
排除标准
- •At both registration and randomisation:
- •Patients with monoclonal gammopathy of uncertain significance.
- •Primary amyloidosis
- •Patients who have received prior allogeneic transplantation < 12 months prior to entering study
- •Patients who have had prior allogeneic transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or lactating women.
- •Known Hepatitis B, Hepatitis C, Human immunodeficiency virus (HIV) infection, other immunosuppressive therapy or autoimmune disease
研究者
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