Phase 2 Study of Concurrent Monosialotetrahexosylganglioside in the Prophylactic Treatment of Bortezomib-induced Peripheral Neuropathy in Patients of Multiple Myeloma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall incidence rate of peripheral neuropathy (PN)
研究概览
简要总结
Bortezomib was an important drug in the treatment of multiple myeloma (MM),and peripheral neuropathy (PN) is a significant dose-limiting toxicity of bortezomib that typically occurs within the first courses of bortezomib, reaches a plateau at cycle 5. Up to now, no effective prophylaxis have been developed for PN. Monosialotetrahexosylganglioside, a nerve-protecting drug,was often used to promote growth of nerve, and function restoration of damaged nerve.Thus,the investigators hypothesized that combination of Monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral neuropathy (PN) and promote the relief of peripheral neuropathy (PN) in multiple myeloma (MM) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Histologic diagnosis of multiple myeloma;
- •Age:18-80 years;
- •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
Monosialotetrahexosylganglioside
each patient in this arm received velcade+dexamethasone (VD) regimen（bortezomib,1.3mg/㎡，subcutaneously injection，d1,8,15,22；dexamethasone,20mg d1-2, 8-9,15-16,22-23）every 4 weeks; and monosialotetrahexosylganglioside was used at the dosage of 100mg/d intravenously at d1-2,8-9,15-16,22-23 every cycle.
干预措施: Monosialotetrahexosylganglioside (Drug)
结局指标
主要结局
overall incidence rate of peripheral neuropathy (PN)
时间窗: up to 6 months
the grade of peripheral neuropathy (PN) was recorded according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
次要结局
- complete rate (CR) rate(up to 6 months)
- duration of peripheral neuropathy (PN)(up to 1 year (about 6 months after the completion of treatment))
研究者
Xia Zhongjun
Professor
Sun Yat-sen University