EUCTR2005-001628-35-AT进行中（未招募）不适用
A Randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation (MMVAR). - MMVAR - originally also known as Velcade IIS
European Group for Blood and Marrow Transplantation (EBMT)0 个研究点目标入组 452 人开始时间: 2007年5月29日最近更新:
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
- 452
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
- •Male or female and at least 18 years of age
- •Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
- •Relapsing of having a progressive disease after an autologous transplantation
- •Relapse as defined by the following:
- •1.reappearance of serum or urinary paraprotein in immunofixation or routine electrophoresis, confirmed by at least one further investigation and excluding oligoclonal immune reconstitution.
- •2.>5% plasma cells in a bone marrow aspirate or on trephine bone biopsy
- •3.development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions. Development of a compression fracture does not exclude response
- •4.development of hypercalcemia, corrected serum calcium >11.5mg/dL or 2.8 mmol/L, that is not attributable to any other cause
- •progressive disease as defined by one of the following:
- •1)>25% increase in the level of the serum monoclonal paraprotein (5g/l increase minimum and at least 2 investigations)
- •2)>25% increase in the 24h urinary light chain excretion (200 mg/d increase minimum and at least 2 investigations)
- •3)>25% increase in plasma cells in a bone marrow aspirate (absolute increase of at least 10%)
- •4)Increase in the size of the existing bone lesions or soft tissue plasmacytomas
- •5)New bone lesions or soft tissue plasmacytomas
- •6)Onset of hypercalcemia not attributable to any other cause.
- •Measurable disease defined as: quantifiable serum monoclonal antibody defined as a serum monoclonal protein >1g/dL for IgG, or >0.5g/dL for IgA
- •Karnofsky performance status >50%
- •Life expectancy of at least 3 months
- •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study
- •Negative serum or urine -HCG pregnancy test at screening for subjects for child bearing potential
- •Voluntary written consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •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 Non-secretory Multiple myeloma
- •· Karnofsky performance status < or equal to 50%
- •·Patient has a platelet count < 40,000 X 109/L within 14 days before enrollment
- •·Patient has an absolute neutrophil count <1.0 X 109/L within 14 days before enrollment
- •·Creatinine clearance <30 mL/minute within 14 days before enrollment
- •·Peripheral neuropaty >= Grade 2
- •·Seropositive for HIV, or active hepatitis A, B or C infection
- •·Pregnant or breastfeeding female
- •·Patient has hypersensitivity to bortezomib, boron or mannitol
- •·Other investigational drugs received 14 days before enrollment
- •·Serious medical or psychiatric illness
- •·Previous or concurrent malignancies at other sites, with the exception of appropriately treated localized epithelial skin or cervical cancer. Patient with remote histories (>5 years) of other cured tumors may be entered
- •·Poorly controlled hypertension, uncontrolled or severe cardiovascular
- •disease or uncontrolled diabetes mellitus
研究者
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