EUCTR2008-006421-13-CZ进行中（未招募）不适用
Multicenter Phase II Study:Bendamustine plus Bortezomib plus Dexamethasone in the treatment of stage II/III relapsed or refractory multiple myeloma - BBD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •Age at least 18 years at the time of signing the informed consent form
- •Life expectancy of at least 3 month
- •Able to adhere to the study visit schedule and other protocol requirements
- •Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements1:
- •oSerum M-protein = 10g/l
- •oUrine light-chain (M-protein) of = 200 mg/24 hours
- •oSerum FLC assay: involved FLC level =10 mg/dl provided sFLC ratio is abnormal
- •Relapsed or refractory MM in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria)
- •All previous cancer therapy, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroid therapy. Localised radiation therapy is allowed, but the increased risk of leukocytopenia, erythrocytopenia and thrombocytopenia based on the combination of a polychemotherapy and radiation therapy has to be considered and a close monitoring of the patients has to be assured.
- •ECOG performance status of minimum 2 at study entry
- •Laboratory test results within these ranges:
- •-Absolute neutrophil count minimum 1.5 x 109/L
- •-Platelet count minimum 75 x 109/L
- •-Total bilirubin not more than 1.5 mg/dL
- •-AST (SGOT) and ALT (SGPT) not more than 2 x ULN or not more than 5 x ULN if hepatic lesions are present.
- •Disease free of prior malignancies for minimum of 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
- •Fertile patients must use effective contraception during and for 6 months after study treatment
- •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
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Pregnant or breast feeding females
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by NCI CTCAE, version 3.0.
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to the study drugs
- •Any prior use of bortezomib or bendamustine in the last six months
- •Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan
- •Known positive for HIV or infectious hepatitis, type A, B or C
- •Active, uncontrolled infections
- •Acute diffuse infiltrative pulmonary disease and pericardial disease
研究者
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