EUCTR2004-002054-55-GB进行中（未招募）1 期
A phase II Clinical Trial of PXD101 in Patients with Advanced Multiple Myeloma - PXD101-301-G
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •INCLUSION CRITERIA
- •1.Signed informed consent
- •2. A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.
- •Diagnostic criteria for multiple myeloma:
- •A Monoclonal immunoglobulin (M-component) in serum of IgG-type > 30 g/l, of IgA type> 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type > 1 g/24 hours.
- •B M-component in serum and/or urine in lower concentration than indicated above in ‘A’.
- •C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor
- •D Osteolytic bone lesions.
- •The diagnosis of multiple myeloma demands one of the following combinations: A+C, A+D, or B+C+D.
- •3.Evaluable disease (as described above)
- •4.Adequate bone marrow and hepatic function including the following:
- •WBC > 2.5 x 109/l, absolute neutrophil count = 1.5 x 109/l, platelets =50x109/l
- •Total bilirubin =1.5 x upper normal limit.
- •AST (SGOT), ALT (SGPT) =2.5 x upper normal limit
- •5. Serum potassium within normal range.
- •6. Age =18 years
- •7.ECOG performance status (PS) =2
- •8.Estimated life expectancy greater than 3 months
- •9. Female patients with reproductive potential with a negative serum pregnancy test within the last 7 days before trial enrollment and use a safe contraceptive during and for a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive.
- •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
- •EXCLUSION CRITERIA
- •1.Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
- •2.Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures.
- •3.Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry
- •4. A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
- •5. Patients with renal insufficiency defined as a calculated creatinine clearance of <45 ml/min.
- •6.Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication
- •7. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- •8. Other malignant diseases requiring treatment
- •9. Non-secretory multiple myeloma or symptomatic amyloidosis
- •10.Pregnant or breast-feeding women
- •11. Women of childbearing age and potential, who do not use effective contraception
- •12. Known HIV positivity
研究者
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