NCT00091624已完成1 期
A Phase I Study of DVd +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
研究概览
简要总结
A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Understand and voluntarily sign an informed consent form.
- •Age greater than 18 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Diagnosed with active multiple myeloma and be considered to have disease progression after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive disease after treatment.
- •Measurable myeloma paraprotein levels in serum (≥ 0.5g/dL) or urine (≥ 0.2 g excreted in a 24-hour collection sample).
- •Eastern Cooperative Group (ECOG) Performance Status of 0-
- •Performance status of 3 and 4 will be allowed if related to bony disease.
- •Bilirubin < 2 x upper limits of normal (ULN).
- •Liver enzymes (ALT or AST) < 3 x ULN.
- •Must have adequate bone marrow function: * Absolute neutrophil count > 1,000 cells/mm3 (1.0 x 109/L) * Platelets ≥ 100,000 cells/mm3 (100 x 109/L) * Hemoglobin ≥ 8 g/dL
- •Must have adequate renal function: creatinine ≤ 2.5 mg/dL.
- •Must have 2-d echocardiogram indicating LVEF ≥ 50% within 42 days prior to first dose of study drug.
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
排除标准
- •Severe infection requiring intravenous antibiotic treatment.
- •Life expectancy of less than 3 months.
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years.
- •Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
- •Subjects who have received > 500mg/m2 of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®.
- •Prior treatment with CC-
- •Prior development of ≥ grade 2 (NCI CTC) allergic reaction/hypersensitivity while taking thalidomide.
- •Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking thalidomide.
- •History of cardiac disease, with New York Heart Association Class II or greater.
- •Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.
- •Any investigational agent or systemic anti-myeloma therapy within 28 days of the first dose of treatment.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or lactating females.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
研究者
研究点 (2)
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