NCT00022282已完成2 期
Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
AEterna Zentaris1 个研究点 分布在 1 个国家开始时间: 2001年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
RATIONALE: AE-941 may help to slow the growth of multiple myeloma.
PURPOSE: Phase II trial to study the effectiveness of neovastat in treating patients who have relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
- Determine the confirmed tumor response rate in patients with early relapse or refractory multiple myeloma treated with AE-941 (Neovastat).
- Determine the safety of this drug in these patients.
- Evaluate the time to progression in patients treated with this drug.
- Evaluate the duration of tumor response (partial response, response, and complete response) in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral AE-941 (Neovastat) twice daily.
Patients are followed every 4 weeks until disease progression.
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 (MM) according to the Durie and Salmon criteria
- •Refractory to or in early relapse after standard chemotherapy with or without stem cell transplantation
- •Measurable disease
- •Quantifiable IgM, IgG, or IgA paraprotein in serum AND/OR
- •Bence-Jones protein in urine
- •No plasma cell leukemia (more than 20% plasma cells in peripheral blood and an absolute plasma cell count of at least 2,000/mm3)
- •No nonsecretory MM
- •No spinal cord compression
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •No clinical symptoms of hyperviscosity
- •Not specified
- •Creatinine no greater than 2 times upper limit of normal
- •Calcium no greater than 11 mg/dL
- •No other prior malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No severe allergy to fish or seafood
- •No medical condition that would interfere with intake and/or absorption of study medication (e.g., gastrectomy or major intestinal resection)
- •No significant medical or psychiatric condition that would preclude study participation
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use adequate contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •No prior history of treatment with thalidomide for more than 14 days duration
- •At least 4 weeks since prior biological therapy for MM
- •Concurrent epoetin alfa allowed
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy for MM
- •Endocrine therapy:
- •At least 4 weeks since prior steroid therapy for MM
- •No prednisone maintenance therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent palliative or curative radiotherapy
- •Not specified
- •At least 28 days since other prior shark cartilage products
- •At least 28 days since other prior experimental therapeutic agents
- •Concurrent monthly bisphosphonate (pamidronates) infusions allowed
- •No other concurrent anticancer treatment
- •No other concurrent shark cartilage products
- •No other concurrent therapies for MM
排除标准
- 未提供
研究者
研究点 (1)
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