EUCTR2006-005890-24-GB进行中（未招募）1 期
Myeloma X Relapse (Intensive) - A randomised controlled trial to determine the role of a second autologous stem cell transplant as consolidation therapy in patients with relapsed multiple myeloma following prior high-dose chemotherapy and autologous stem cell rescue. - Myeloma X Relapse (Intensive)
eeds Teaching Hospitals NHS Trust0 个研究点目标入组 297 人开始时间: 2007年10月10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
- 297
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
- •The principal inclusion criteria for registration are:
- •1) Diagnosed with symptomatic including non-secretory myeloma previously treated with standard chemotherapy and autologous transplantation
- •2) Requiring therapy for first Progressive Disease
- •3) Demonstrate Progressive Disease requiring treatment at least 18 months from time of first transplant
- •4) Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •5) Aged at least 18 years
- •6) Adequate full blood count, renal function, hepatobililiary function, pulmonary function and cardiac function within 14 days of registration
- •7) If female and of childbearing potential, must have a negative pregnancy test within 24 hours prior to start of PAD (bortezomib, doxorubicin, dexamethasone) therapy
- •8) Provide written informed consent
- •The principal inclusion randomisation are: As at registration, plus
- •1) Responded or have Stable Disease, following PAD re-induction chemotherapy
- •2) Adequate stem cell mobilisation defined as =2x10^6 CD34+ cells/kg or = 2x10^8 PBMC/kg available for transplantation (including cells stored from a previous harvest)
- •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
- •The principal exclusion criteria for registration are:
- •1) Received therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone up to a maximum of 200mg
- •2) Greater than or equal to Grade 2 peripheral neuropathy within 14 days before registration
- •3) Known HIV or Hepatitis B/C seropositivity (testing is not required for the trial).
- •4) Use of any investigational drug within 4 weeks prior to registration, or scheduled to receive any investigational drug during the course of the study.
- •5) Known resistance to combined bortezomib, doxorubicin and dexamethasone (PAD) therapy
- •6) Known history of allergy contributable to compounds containing boron or mannitol 7) Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient’s participation in this study.
- •8) Previous or concurrent malignancies at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with remote histories (>5 years) of other cured tumours may be entered.
- •9) Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment if female of childbearing potential, or male whose partner is a female of childbearing potential unless they are surgically sterile.
- •The principal exclusion criteria for randomisation are:
- •1) Progressive Disease, according to International Uniform Response Criteria for myeloma, following PAD re-induction therapy or stem cell mobilisation
- •2) Received any therapy for their relapsed disease other than local radiotherapy or protocol PAD treatment prior to randomisation
- •3) Any contraindication to protocol treatment that would make the patient ineligible
研究者
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