NCT00742404Unknown2 期
A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)
Oncotherapeutics24 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年7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
- 35
- 试验地点
- 24
- 主要终点
- Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with bortezomib and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To determine the response rate (i.e., complete response, very good partial response , partial response, and minimal response) in patients with newly diagnosed multiple myeloma treated with pegylated liposomal doxorubicin hydrochloride, bortezomib, and dexamethasone.
Secondary
- To assess the safety and tolerability of this regimen in these patients.
- To determine the time to disease progression, time to response, duration of response, progression-free survival, and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of multiple myeloma based on the following criteria:
- •Major criteria
- •Plasmacytomas on tissue biopsy (1)
- •Bone marrow plasmacytosis (> 30% plasma cells) (2)
- •Monoclonal immunoglobulin spike on serum electrophoresis IgG > 3.5 g/dL or IgA > 2.0 g/dL and kappa or lambda light chain excretion > 1 g/day on 24-hour urine protein electrophoresis (3)
- •Minor criteria
- •Bone marrow plasmacytosis (10% to 30% plasma cells) (a)
- •Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria (b)
- •Lytic bone lesions (c)
- •Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL (d)
- •Meets 1 of the following sets of diagnostic criteria:
- •Any two of the major criteria
- •Major criteria 1 and minor criteria b, c, and d
- •Major criteria 3 and minor criteria a or c
- •Minor criteria a, b, c, OR a, b, d
- •Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24 hours, or evidence of lytic bone disease
- •No nonmeasurable disease (i.e., non-secretory or oligosecretory multiple myeloma)
- •Symptomatic, newly diagnosed, and previously untreated multiple myeloma
- •No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein], and skin changes)
- •No plasma cell leukemia
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Life expectancy > 3 months
- •ANC ≥ 1,500/mm^³ (≥ 1,000/mm^³ if bone marrow is extensively infiltrated)
- •Platelet count ≥ 75,000/mm^³ (≥ 50,000/mm^³ if bone marrow is extensively infiltrated)
- •Hemoglobin ≥ 8.0 g/dL
- •AST and ALT ≤ 3.0 times upper limit of normal (ULN)
- •Serum bilirubin ≤ 2.0 times ULN
- •Creatinine clearance ≥ 30 mL/min OR creatinine > 10 mL/min and < 30 mL/min for patients with significant myelomatous involvement of the kidneys
- •Serum potassium ≥ lower limit of normal (LLN)
- •Serum sodium ≥ LLN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No peripheral neuropathy ≥ grade 2 within past 14 days
- •No impaired cardiac function or clinically significant cardiac disease, including any one of the following:
- •Myocardial infarction within the past 6 months
- •New York Heart Association class II-IV heart failure
- •Uncontrolled angina
- •Clinically significant pericardial disease
- •Severe uncontrolled ventricular arrhythmias
- •LVEF below normal by ECHO or MUGA scan
- •ECG evidence of acute ischemia or active conduction system abnormalities
- •Screening ECG abnormality must be documented by the investigator as not medically relevant
- •No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL [3.5 mmol/L])
- •No poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could preclude study treatment
- •No known HIV positivity or hepatitis B or C positivity
- •Baseline testing for HIV and hepatitis B or C is not required
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study
次要结局
- Changes in serum M-protein
- Changes in 24-hour urine M-protein
- Time to progression
- Overall survival
- Safety and tolerability as assessed by NCI CTCAE v3.0
- Time to response
- Progression-free survival
- Duration of response
研究者
研究点 (24)
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