Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Induction therapy: response rate, overall survival, death rate
研究概览
简要总结
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple myeloma.
Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID.
详细描述
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.
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 multiple myeloma according to British Columbia Cancer Agency Criteria
- •Stage IIA/B or IIIA/B according to Durie/Salmon
- •Symptomatic or progressive disease
- •Status of disease:
- •refractory disease after standard induction therapy
- •OR relapse after standard induction therapy
- •OR relapse after high-dose chemotherapy/stem cell transplantation
- •OR patients with plasma cell leukemia
- •Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
- •Written informed consent
排除标准
- •Age < 18 years
- •Life expectancy of less than 3 months
- •Intolerance to the study drugs
- •No change or progressive disease after prior therapy with idarubicin or cyclophosphamide
- •Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4
- •Acute infection
- •Actually decompensated diabetes mellitus
- •Total bilirubin > 3.0 mg/dl
- •Pregnant or breast-feeding women
- •Polyneuropathy grade 2 or higher
- •Ulcus ventriculi or duodeni
- •Narrow or open angle glaucoma
- •Not-compensated psychiatric diseases
- •Prior erythroblastopenia
- •Prior therapy with investigational drugs within the last 4 weeks
结局指标
主要结局
Induction therapy: response rate, overall survival, death rate
Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity
次要结局
- Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
- Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4