EUCTR2005-000395-41-IE进行中（未招募）1 期
Phase II Study to Assess the Safety, Efficacy, and Tolerability of Combination Therapy with Velcade? (Bortezomib), Adriamycin, and Dexamethasone (PAD) as Therapy for Patients with relapsed or refractory Multiple Myeloma - PAD Protocol
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 69
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
- •Patients aged at least 18 years with MM requiring therapy for relapsed or refractory disease.
- •Previous VAD or VAD-like therapy (maximum 6 courses standard VAD). Subgroup allocation is shown in 4.1
- •Measurable serum and/or urine paraprotein, or serum free light chain
- •Performance Status (PS) 0-3 (ECOG - see Appendix B)
- •Serum bilirubin values <1.5 times the upper limit of normal
- •Serum ALT/AST values <2.5 times the upper limit of normal
- •Able to give 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
- •Females of child-bearing potential without a negative pregnancy test, immediately prior to the start of PAD therapy and/or unwilling to use barrier contraceptive precautions throughout the study or who are pregnant or breast-feeding
- •Patients with non-secretory MM and no measurable elevation of serum free light chain
- •Performance status 4 (ECOG)
- •Patient has a platelet count <75 x 10 9/L within 14 days before enrolment
- •Patient has an absolute neutrophil count <1.0 x 10 9/L within 14 days before enrolment
- •Patient has a serum creatinine > 400 umol/l at the time of enrolment
- •Patient has >_Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) within 14 days before enrolment
- •Cardiac ejection fraction <40% by echocardiography or MUGA scan
- •Known HIV seropositivity (obligatory testing is not necessary)
- •Known Hepatitis B or C (obligatory testing is not necessary)
- •Patients who have received more than one autologous transplant
- •Use of any investigational drug within 4 weeks prior to enrolment or any patients scheduled to receive any investigational drug during the course of the study
- •Previous Bortezomib therapy
- •Patients who have a medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient’s participation in this study
- •Previous or concurrent malignancies at other sites, with the exception of appropriately treated localized epithelial skin or cervical cancer. Patients with remote histories (>5 years) of other cured tumours may be entered
- •Plasma exchange within 21 days of enrolment
研究者
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