Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) Who Are Eligible for Autologous Stem Cell Transplantation: Multicenter Phase 2 Study
试验速览
- 阶段
- 2 期
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- response rate for induction chemotherapy
研究概览
简要总结
In this study, the investigators will analyze the long-term outcomes of remission and survival, and identify those with primary resistant disease as more likely to benefit from CTD (thalidomide, cyclophosphamide, dexamethasone) and early intensification of Vel-CD (bortezomib and CD) as induction chemotherapy followed by autologous stem cell transplantation for the patients with newly diagnosed multiple myeloma.
详细描述
This study aims to assess the efficacy and toxicities of CTD and Vel-CD induction followed by high-dose therapy with autologous stem cell transplantation as a first line treatment for the patients with multiple myeloma.The investigators already investigated the thalidomide-based chemotherapy in patients with newly diagnosed MM. The combined regimen consisted of cyclophosphamide, thalidomide and dexamethasone (CTD) for induction treatment. CTD chemotherapy resulted in a favorable response with 79.4% overall response rate including 42.6% complete response (CR) or very good partial complete response (VGPR), and tolerable toxicity in MM patients. Moreover, CTD chemotherapy did not affect the yield of the stem cell collection.The investigators also published that the clinical efficacy and safety of a four-drug combination of bortezomib, cyclophosphamide, thalidomide, and dexamethasone was assessed for patients with relapsed or refractory multiple myeloma Vel-CTD chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed MM
- •Aged between 18 and 65 years old
- •With following measurable lesions (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day, or free light chain ≥ 100 mg/L)
排除标准
- •Smoldering or indolent myeloma
- •ECOG performance status > 3 point
- •Known hypersensitivity to cyclophosphamide, thalidomide or dexamethasone
- •Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
- •Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, NYHA Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg
- •Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal)
- •Creatinine clearance < 20 ml/min
- •Corrected serum calcium ≥ 14 mg/dL
- •Sepsis or current active infection
- •Pregnancy or breast feeding
- •Uncontrolled Diabetes Mellitus
- •Previous history of Recurrent DVT or pulmonary embolism
- •Active ulcers detected by gastroscopy
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Receipt of extensive radiation therapy within 4 weeks
结局指标
主要结局
response rate for induction chemotherapy
时间窗: 2 years
次要结局
未报告次要终点