EUCTR2008-004264-39-GB进行中（未招募）1 期
A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Effect of VELCADE® on Myeloma related Bone Disease
Janssen-Cilag EMEA Medical Affairs0 个研究点目标入组 104 人开始时间: 2009年4月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Man or woman over 18 years of age
- •2. Response of PR or better after receiving high-dose chemotherapy followed by autologous stem cell transplantation (single- or double transplant) as primary therapy of the disease. Date of hospital discharge from stem cell transplantation has to be at least 60 days and within 120 days prior to randomization.
- •3. Karnofsky performance status of = 60
- •4. Life expectancy estimated at screening of at least 12 months
- •5. Following pre-treatment laboratory criteria at and within 14 days before baseline (Day 1 of Cycle 1, before study drug administration):
- •Platelet count = 50x 109/L without transfusion support within the 7 days before the test
- •Haemoglobin = 7.5 g/dL without transfusion support within the 7 days before the test
- •Absolute neutrophil count (ANC) = 0.75 x10 9/L without the use of colony stimulating factors
- •within 14 days before the test
- •Corrected serum calcium < 14 mg/dL (3.5 mmol/L)
- •Aspartate transaminase (AST): <= 2.5 x the upper limit of normal (ULN)
- •Alanine transaminase (ALT): <= 2.5 x ULN
- •Total bilirubin: <= 1.5 x ULN
- •6. Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclision criteria
- •1. Received another antimyeloma or experimental therapy following autologous stem cell transplantation
- •2. Known allergies, hypersensitivity, or intolerance to study drug or its excipients
- •3. [Exclusion criterion no. 3 is deleted.]
- •4. Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by the National Cancer
- •Institute Common Terminology Criteria of Adverse Events (NCI CTCAE), version 3.0
- •5. Myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or
- •IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic
- •evidence of acute ischemia or active conduction system abnormalities
- •6. Poorly controlled hypertension, diabetes mellitus, or other serious medical condition (such as severe
- •hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections,
- •etc) or psychiatric illness likely to interfere with participation in this clinical study*
- •7. Treated for a cancer other than multiple myeloma within 5 years before enrolment, with the exception of
- •basal cell carcinoma or cervical cancer in situ
- •8. Known to be human immunodeficiency virus (HIV)-positive (Subjects assessed by the investigator to be at
- •risk for HIV infection should be tested in accordance with local policies.)
- •9. Known to be hepatitis B surface antigen-positive or known active hepatitis C infection (Subjects assessed
- •by the investigator to be at risk for hepatitis B or C infection are to be tested in accordance with local
- •regulations.)
- •10. Active systemic infection requiring treatment
研究者
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