Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with overall hematologic response
研究概览
简要总结
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.
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
- •Male or female patients from 18 to 80
- •Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
- •Disease requiring further treatment
- •Measurable disease such as M protein and Objective and measurable of EMP
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- •Meet the clinical laboratories criteria as specified in the protocol
- •Voluntary written consent
排除标准
- •Female patients who are lactating, breastfeeding or pregnant
- •Evidence of current uncontrolled cardiovascular conditions as specified in study protocol
- •Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP.
- •Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Ongoing or active infection, known HIV positive, active hepatitis B or C infection
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Known allergy to any of the study medications
研究组 & 干预措施
CDD Plus Bortezomib
Patients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity.
干预措施: CDD Plus Bortezomib (Drug)
CDD
Dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity
干预措施: CDD (Drug)
结局指标
主要结局
Number of patients with overall hematologic response
时间窗: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)
Complete response, very good partial response and partial response
次要结局
- Number of patients with EMP response(Assessed every 2 cyeles period is projected to be approximately 24 months)
- Time from diagnosis ofEMP to the date of death(Monthly up to 3 years)
- Overall survival(Monthly up to 3 years)
- Progression free survival(Monthly up to 2 years)
- Time from date of diagnosis of EMP to the date of first documentation of disease(Monthly up to 2 years)
- Number of adverse events(Monthly up to 3 years)
研究者
Yuping Zhong
Chief physician
Beijing Chao Yang Hospital