EUCTR2005-000395-41-GB进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 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
- •Patients with Acute Diffuse Infiltrative Pulmonary Disease (ADIPD)
- •Patients with Pericardial disease
- •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
- •Men with partners of child bearing potential unwilling to use a medically acceptable form of contraception
- •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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