NCT00346255已完成1 期
A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 11
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed and/or refractory multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and the maximum tolerated dose of BB-10901 in patients with relapsed and/or refractory CD56-positive multiple myeloma.
Secondary
- To determine the qualitative and quantitative toxicities of BB-10901 administered on this schedule.
- To evaluate the pharmacokinetics of BB-10901.
- To recommend a dose for Phase II clinical studies with BB-10901 given on this specific regimen.
- To observe any evidence of anti-tumor activity with BB-10901.
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
- 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:
- •Histologically confirmed multiple myeloma
- •Relapsed or relapsed/refractory disease
- •Failed ≥ 1 prior therapy for multiple myeloma
- •Once the MTD is defined, only patients who have received at least 1 but equal or less than 6 prior chemotherapy regimens will be enrolled at this dose level
- •CD56-positive disease confirmed by immunohistochemistry or flow cytometry
- •PATIENT CHARACTERISTICS:
- •ECOG (Zubrod) performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Platelet count ≥ 75,000/mm^3
- •Absolute neutrophil count > 1,000/mm^3
- •Hemoglobin ≥ 8.5 g/dL
- •AST and ALT ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Amylase and lipase within normal limits
- •Creatinine ≤ 2 mg/dL
- •Left ventricular ejection fraction ≥ lower limit of normal on MUGA or ECHO
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No peripheral neuropathy ≥ grade 3 or painful grade 2 neuropathy
- •No significant cardiac disease, including any of the following:
- •Myocardial infarction within the past 6 months
- •Unstable angina
- •Uncontrolled congestive heart failure
- •Uncontrolled hypertension (i.e., recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)
- •Uncontrolled cardiac arrhythmias
- •Cardiac toxicity ≥ grade 3 after prior chemotherapy
- •No history of multiple sclerosis or other demyelinating disease
- •No hemorrhagic or ischemic stroke within the past 6 months
- •No Eaton-Lambert syndrome (para-neoplastic syndrome)
- •No CNS injury with residual neurological deficit (other than peripheral neuropathy ≤ grade 2)
- •No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer
- •No clinically relevant active infection, including active hepatitis B or C infection or HIV infection
- •No other condition or disease, including laboratory abnormalities, that, in the opinion of the investigator, may preclude study treatment
- •No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- •At least 4 weeks since prior radiotherapy
- •At least 4 weeks since prior major surgery (except placement of a vascular access device or tumor biopsies)
- •More than 4 weeks since prior investigational agents
- •At least 2 weeks since prior antineoplastic therapy with biological agents
- •No prior hypersensitivity to monoclonal antibody therapy
- •No other concurrent investigational agents
- •No concurrent corticosteroids (except as indicated for other medical conditions [< 10 mg prednisone or equivalent]; as pre-medication for administration of certain medications or blood products [≤ 100 mg hydrocortisone]; or for treatment of infusion reactions)
- •Concurrent topical steroids allowed
- •No other concurrent antineoplastic treatment (e.g., chemotherapy, radiotherapy, or biological agents)
- •Concurrent bisphosphonates allowed provided patient began bisphosphonates before study entry and is maintained on a stable dose during study treatment
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity
时间窗: through cycle 1
Maximum tolerated dose
时间窗: for the duration of the study
次要结局
- Qualitative and quantitative toxicities(for the duration of the study)
- Pharmacokinetics(for the duration of the study)
- Anti-tumor activity including overall response rate, time to progression and survival(for the duration of the study)
研究者
研究点 (11)
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