A Phase 3 Trial Comparing Cyclophosphamide,Bortezomib,and Dexamethasone (CyBorD) and Bortezomib,Doxorubicin,and Dexamethasone (PAD) in the Treatment of Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy
研究概览
简要总结
Bortezomib-based triple-drug combination has greatly improved the response rate of multiple myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical practice.Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients.In this study, the investigators will compare the efficacy and safety of these two regimens using once-weekly subcutaneous injection of bortezomib.
详细描述
Bortezomib-based triple-drug combination has greatly improved the response rate of multiple myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical practice. Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients. Moreover, studies have found that subcutaneous injection of bortezomib can decrease the incidence rate of peripheral neuropathy induced by bortezomib, however, most center use twice-weekly administration of bortezomib. According to our experience, once-weekly subcutaneous injection of bortezomib can further decrease the incidence rate of peripheral neuropathy without compromising the efficacy. Thus, in this phase 3 trial, the investigators will compare the efficacy and safety of these two regimens using once-weekly subcutaneous injection of bortezomib.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosis of multiple myeloma
- •Eastern Cooperative Oncology Group (ECOG) status 0-3,
- •Estimated survival time > 3 months
- •Acceptable liver function (bilirubin<2.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)<2.5×ULN)
- •No history of other malignancies
- •No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
- •No other serious diseases which conflict with the treatment in the present trial
- •No concurrent treatments that conflict with the treatments in the present trial
- •Voluntary participation and signed the informed consent.
排除标准
- •The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication;
- •The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
- •The patients with neuropathy
- •The patients with mentally ill / unable to obtain informed consent
- •The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
- •The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
- •The patients with a history of allergy to test drug
- •The patients not suitable to participate in the investigator judged by researchers.
研究组 & 干预措施
CyBorD regimen
this arm will receive cyclophosphamide (500mg/d,once-weekly),bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), and dexamethasone (40mg/d,once-weekly)(CyBorD) as induction therapy.
干预措施: Cyclophosphamide (Drug)
CyBorD regimen
this arm will receive cyclophosphamide (500mg/d,once-weekly),bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), and dexamethasone (40mg/d,once-weekly)(CyBorD) as induction therapy.
干预措施: Bortezomib (Drug)
CyBorD regimen
this arm will receive cyclophosphamide (500mg/d,once-weekly),bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), and dexamethasone (40mg/d,once-weekly)(CyBorD) as induction therapy.
干预措施: Dexamethasone (Drug)
PAD regimen
this arm will receive bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), dexamethasone (40mg/d,once-weekly), and doxorubicin (9mg/㎡，d1-4)(PAD) as induction therapy.
干预措施: Bortezomib (Drug)
PAD regimen
this arm will receive bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), dexamethasone (40mg/d,once-weekly), and doxorubicin (9mg/㎡，d1-4)(PAD) as induction therapy.
干预措施: Dexamethasone (Drug)
PAD regimen
this arm will receive bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), dexamethasone (40mg/d,once-weekly), and doxorubicin (9mg/㎡，d1-4)(PAD) as induction therapy.
干预措施: Doxorubicin (Drug)
结局指标
主要结局
At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy
时间窗: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)
compare the Response assessment in both arms: the Very good partial response rate (according to the criteria IMWG) achieved with four courses of CyBorD with with that achieved with four courses of PAD
次要结局
- complete response rate(according to the criteria IMWG) after four cycles of induction therapy(date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months))
- At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy(date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months))
研究者
Xia Zhongjun
Doctor
Sun Yat-sen University