NCT00085345撤回2 期
Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
Oncotherapeutics37 个研究点 分布在 1 个国家开始时间: 2004年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 37
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.
PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
- Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the time to response and overall survival of patients treated with this regimen.
- Determine the effects of this regimen on renal failure associated with MM in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 meeting at least 1 of the following criteria:
- •Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or first-line high-dose chemotherapy
- •Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids
- •Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
- •No non-secretory myeloma
- •No plasma cell leukemia
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated)
- •Hemoglobin ≥ 8.0 g/dL
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Pancytopenia secondary to multiple myeloma or hypersplenism allowed
- •AST and ALT ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 2 times ULN (unless clearly related to disease)
- •No known active hepatitis B or C infection
- •Calcium < 14 mg/dL
- •Cardiovascular
- •No evidence of acute ischemia or new conduction system abnormality by electrocardiogram
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class III or IV heart failure
- •No poorly controlled hypertension
- •No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium ≥ 1.8 mmol/L
- •No active infection
- •No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •No diabetes mellitus
- •No other serious medical or psychiatric illness that would preclude study participation
- •No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
- •No history of grand mal seizures
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy or antibody therapy
- •Chemotherapy
- •See Disease Characteristics
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Endocrine therapy
- •See Disease Characteristics
- •No other concurrent corticosteroids
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •More than 4 weeks since prior major surgery
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (37)
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