NCT00526734Unknown2 期
A Randomised, International, Open-label, Phase II Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization and Engraftment With Pegfilgrastim or Filgrastim for Autologous Transplantation in Patients With Multiple Myeloma (MM)
Erasme University Hospital8 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Number of patients with engraftment after induction chemotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps stem cells move from the bone marrow to the blood so they can be collected. It is not yet known which regimen is more effective in treating multiple myeloma.
PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or stage III multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Compare engraftment of peripheral blood progenitor cells (PBPCs) mobilized by 2 different fixed doses of pegfilgrastim versus a by-weight dose of filgrastim (G-CSF).
Secondary
- Determine the ability of 2 different fixed doses of pegfilgrastim to mobilize PBPCs.
- Determine the safety of pegfilgrastim during PBPC mobilization and collection.
- Determine the effect of different induction chemotherapy regimens on autologous progenitor cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of symptomatic stage I or stage II-III multiple myeloma
- •Newly diagnosed disease
- •No amyloidosis
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0-2
- •ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors)
- •Platelet count ≥ 50 x 10^9/L (without transfusion support within the past 7 days)
- •Serum calcium < 14 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 times ULN
- •Creatinine clearance ≥ 50 mL/min
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •Willing and able to comply with protocol requirements
排除标准
- •Myocardial infarction within the past 6 months
- •New York Heart Association class III or IV heart failure
- •Uncontrolled angina
- •Severe uncontrolled ventricular arrhythmia
- •Acute ischemia or active conduction system abnormalities as evidenced by ECG
- •Serious medical condition that could prolong hematological recovery or preclude completion of or tolerance to protocol therapy
- •Seropositive for HIV antibody
- •Known hepatitis B surface antigen positivity OR active hepatitis C infection
- •Active systemic infection requiring treatment
- •Pregnant or nursing
- •Poor psychiatric condition
- •PRIOR CONCURRENT THERAPY:
- •No plasmapheresis within the past 4 weeks
- •No major surgery within the past 4 weeks
- •No anticancer therapy within the past 5 years, except treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
- •No other concurrent G-CSF growth factors
- •No concurrent enrollment in another investigational clinical trial
- •No concurrent investigational agent that would contraindicate the use of pegfilgrastim as either a mobilization agent or a hematological recovery agent
结局指标
主要结局
Number of patients with engraftment after induction chemotherapy
次要结局
- Number and proportion of patients from whom ≥ 2 x 10e6 CD34-positive cells/kg are harvested
- Number and proportion of patients from whom ≥ 4 x 10e6 CD34-positive cells/kg are harvested
- CD34-positive cells/kg yield in each leukapheresis
- Number of leukaphereses to collect ≥ 2 x 10e6 CD34-positive cells/kg
- Number of leukaphereses to collect ≥ 4 x 10e6 CD34-positive cells/kg
- Proportion of patients with platelet recovery ≥ 20 x 10e9/L in the absence of transfusion for at least 7 days
- Proportion of patients with ANC recovery of ≥ 0.5 x 10e9/L
- Time to neutrophil recovery, defined as the time to neutrophil engraftment (i.e., ANC ≥ 0.5 x 10e9/L for 3 consecutive days)
- Time to ANC ≥ 1.0 x 10e9/L
- Time to platelet recovery, defined as the time to platelets ≥ 20 x 10e9/L in the absence of platelet transfusion support for at least 7 days
- Incidence and duration of hospitalization during mobilization phase and during post-transplantation phase
- Incidence and severity of adverse events during and after the use of pegfilgrastim 12 mg or pegfilgrastim 18 mg and filgrastim
研究者
研究点 (8)
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