NCT00293111终止2 期
An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)
Cephalon16 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2002年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 16
研究概览
简要总结
An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)
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
- •Previously diagnosis of multiple myeloma as determined by any two of the major criteria, or major criteria 1 plus minor criteria b, c, or d, or major criteria 3 plus minor criteria a or c, or minor criteria a, b and c or a, b, and d.
- •Major criteria:
- •Plasmacytomas on tissue biopsy
- •Bone marrow plasmacytomas (>30% plasma cells)
- •Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) >3.5 g/dl or immunoglobulin A (IGA) > 2.0 g/dl; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis
- •Minor criteria:
- •Bone marrow plasmacytomas (10 to 30% plasma cells)
- •Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- •Lytic bone lesions
- •Normal IgM < 50 mg/dl, IgA < 100 mg/dl, or IgG < 600 mg/dl
- •Has relapsed or refractory disease as determined by the following:
- •Relapsed disease:
- •Disease progression developed following the achievement of at least stable disease or better to an anti-myeloma regimen.
- •Refractory disease:
- •Disease progression developed during therapy with an anti-myeloma regimen prior to the achievement of at least stable disease or better. Includes the development of disease progression during maintenance or consolidation therapy with glucocorticoids or cytotoxic chemotherapy.
- •Age > 18 at signing of informed consent.
- •ECOG performance status 0-
- •Renal function 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine
- •Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
- •Female patients of childbearing potential must have a negative pregnancy test (serum -human chorionic gonadotropin, -HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 1 month following completion of treatment.
- •Signed IRB-approved informed consent by patient prior to all study related procedures.
排除标准
- •History of a prior malignancy with in the last 3 years with the exception of resected basal cell carcinoma, in situ cervical cancer at any time or other resected malignancies with no evidence of recurrence 5 or more years since diagnosis.
- •Patients with a hemoglobin count of < 8.0 g/dl, platelet count of < 50,000 cells/mm3, or an absolute neutrophil count (ANC) of < 1000 cells/mm
- •Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, places the subject at unacceptable risk or might interfere with the achievement of the study objectives.
- •Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
- •Peptic ulcer disease (PUD) requiring treatment or surgical intervention within the last 2 years.
- •The use of steroids or chronic nonsteroidal anti-inflammatory drugs 28 days prior to the initiation of study medication.
- •Treatment with chemotherapy for the treatment of multiple myeloma or any investigational agent within 6 weeks of study entry.
- •History of allergy to NSAIDs or aspirin-induced asthma.
- •Pregnancy or currently breast feeding.
研究者
研究点 (16)
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