EUCTR2005-003001-85-CZ进行中（未招募）不适用
Bortezomib-Doxorubicin-Dexamethasone (BDD) as Treatment for Patients with Multiple Myeloma Presenting with Acute Renal Failure - BDD
Austrian Forum against Cancer0 个研究点目标入组 50 人开始时间: 2006年4月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •- Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
- •- Acute renal failure in patients with multiple myeloma
- •- by newly diagnosed patients: glomerular filtration rate (< 50ml/min). Diagnosis of paraprotein induced renal failure must be established (by clinical and laboratory findings including kidney biopsy-if indicated);
- •- by previously treated patients (without limitation by number of treatment lines): decrease in GFR > 25% compared to pre renal failure level (within 4 weeks), or to <50ml / min, concomitantly with either increase in paraproteins (>25%) and/or decrease in hemoglobin = 2 g/dl (within 4 weeks) and/or increase in bone marrow plasma infiltration as signs of disease progression;
- •- Age > 20 years
- •- ECOG performance status of = 3 (Appendix IV)
- •- Platelet count > 50.000/µl
- •- WBC > 2000/µl
- •- Neutrophils ³ 1000/µl
- •- Total bilirubin < 1.5 x upper limit of normal, AST, ALT < 2.5 x upper limit of normal
- •- Fertile women and men of childbearing potential (<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile);
- •- Negative serum or urine ß-HCG pregnancy test at screening for subjects of child-bearing potential
- •- Patient’s written informed consent
- •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
- •- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years
- •- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- •- Evidence of CNS involvement or spinal cord compression.
- •- Neuropathy = Grade 2
- •- A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drug.
- •- NYHA Status > 2, i.e. clinically significant cardiac disease, (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias, and arterial hypertension not well controlled with medication) or myocardial infarction within the last 6 months (see also Appendix VIII).
- •- Evidence of bleeding diathesis or coagulopathy
- •- Serious, non-healing wound or ulcer
- •- Evidence of any severe active acute or chronic infection.
- •- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- •- Patient is known to be HIV-positive, Hbs-antigen positive or HCV-RNA-positive
- •- Pregnant women or nursing mothers
- •- Have received bortezomib within 4 weeks before the planned start of treatment
- •- Half body irradiation < 28 days before enrollment
- •- Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
研究者
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