A Randomized Evaluation of Vinorelbine Versus Gemcitabine for Mobilization of Peripheral Stem Cells in Myeloma Patients Undergoing Autologous Stem Cell Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- CD34+ (cluster of differentiation 34) peripheral blood stem cells
研究概览
简要总结
The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients
详细描述
Mobilization and engraftment of autologous peripheral blood progenitor cells (PBPC) in newly diagnosed multiple myeloma (MM) or amyloidosis patients followed by high dose chemotherapy with PBPC support.
Eligible are symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
Chemotherapy with vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chlorid) as an infusion over 30 minutes, on an ambulatory basis.
G-CSF (granulocyte-colony stimulating factor) is given at 60 Mio s.c./d for patients ≤ 69kg in two daily doses of 30 Mio 12 hours apart, at 78 Mio s.c./d for patients from 70kg to 89kg with 48 Mio given in the morning and 30 Mio given in the evening, and at 96 Mio s.c./d for patients ≥ 90kg in two daily doses of 48 Mio.
Patients will be randomized in a 1:1 ratio between vinorelbine and gemcitabine mobilization. Patients will be stratified according to (A) response to induction treatment (refractory/stable disease/partial response versus very good partial response/complete response) and (B) peripheral neuropathy present versus absent before mobilization.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
- •Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (less than 5 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD (vincristine, adriamycin and dexamethasone) regimen.
- •Patient must be aged 18-75 years, with an ECOG (Eastern Cooperative Oncology Group) < 3, and has given voluntary written informed consent.
- •Patient has the following laboratory values at baseline:
- •Platelets count > 50 x 109/l without transfusion support within 7 days before the laboratory test.
- •Absolute neutrophil count (ANC) > 1.0 x 109/l without the use of colony stimulating factors.
- •Creatinine-clearance > 40 ml/min
- •Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months. No pregnant or lactating patients are allowed.
排除标准
- •Patients with more than 4 cycles of chemotherapy with lenalidomide.
- •Patients not fit for autologous stem cell transplantation
- •Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
- •Subject is currently enrolled in another investigational trial or is receiving other investigational agent(s).
研究组 & 干预措施
Mobilisation Chemotherapy: Vinorelbine
Vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis.
干预措施: Vinorelbine (Drug)
Mobilisation Chemotherapy: Gemcitabine
Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chloride) as an infusion over 30 minutes, on an ambulatory basis.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
CD34+ (cluster of differentiation 34) peripheral blood stem cells
时间窗: Day 8
Number of patients with collection of \> 6 million CD34+ peripheral blood stem cells/kg body weight at day 8 after vinorelbine versus gemcitabine chemotherapy
次要结局
- Rate of peripheral neuropathy(Between 15 and 30 days)
- Severity of peripheral neuropathy(Between 15 and 30 days)
- Hematologic recovery(Between 15 and 30 days)
- Minimal residual disease in the peripheral blood(Day 8)
- Need to use the stem cell releasing compound Plerixafor(Day 8)
- Response Rate(Between 15 and 30 days)