EUCTR2005-003843-30-DE进行中（未招募）不适用
Bortezomib and Bendamustine in the Treatment of Refractory/Relapsed Multiple Myeloma
ORTHO BIOTECH, Division of JANSSEN-CILAG GmbH0 个研究点目标入组 44 人开始时间: 2005年9月26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
- 44
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
- •1. Male and female myeloma patients aged between 18 and 80 years
- •2. Cytologically and/or histologically established multiple myeloma requiring treat-
- •ment, ISS stage II or III.
- •3. 1.-3. Relapse or progression with measurable myeloma protein in the blood or
- •urine following chemotherapy or high-dose therapy with autologous stem cell
- •transplantation
- •4. Patient’s written informed consent has been obtained
- •5. Women must be either post-menopausal or previously sterilised; patients of
- •childbearing potential must:
- •a) use a safe method of contraception during treatment and for 6 months after com-
- •pletion (oral combination contraceptives, depot injections, implantates, IUDs
- •(hormonal IUD acting as a combination of mechanical and hormonal contra-
- •ceptive), sexual abstinence, vasectomized partner)
- •b) have a negative pregnancy test at time of screening6. Male patients must use a
- •reliable method of contraception during treatment and up to 6 months after com-
- •pletion.(Men who are planning to have children should be offered the option of
- •sperm cryopreservation.)
- •7. Karnofsky status >= 60%
- •8. AST (S-GOT) or ALT (S-GPT) less than 2.5 times the upper limit of normal
- •9. Total bilirubin less than 1.5 times the upper limit of normal
- •10. Adequate hematological functions:
- •leukocytes >= 3.0 x 109/l
- •neutrophils >= 1.5 x 109/l
- •platelets >= 75 x 109/l
- •11. Creatinine clearance > 30 ml/min
- •12. Adjusted serum calcium < 14 mg/dl (3.5 mmol/l)
- •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
- •1. Nonsecretory multiple myeloma
- •2. Previous treatment with bendamustine and/or bortezomib within the past
- •3. Previous allogeneic transplantation
- •4. Known allergic reaction to bortezomib, bendamustine, boron, or mannitol
- •5. Life expectancy of less than 3 months
- •6. Malignant neoplasia (except basalioma) within the past 5 years
- •7. Peripheral neuropathy of NCI-CTC grade >= 2
- •8. Other severe comorbidities which, in the attending physician’s opinion, preclude
- •involvement in the trial:
- •a) hepatic or renal insufficiency; clinically relevant pulmonary or gastrointestinal con-
- •b) cardiac failure > NYHA II; myocardial infarction within 6 months prior to screening;
- •Screening; pectoral angina; cardiac arrhythmia (> Lown IVb);
- •ECG evidence of acute ischaemia;
- •Conduction disorders; cardiac amyloidosis
- •c) Systemic infection requiring treatment
- •d) Poorly controlled hypertension or other clinically relevant vascular conditions
- •e) Poorly controlled Diabetes mellitus or other clinically relevant endocrine or meta-
- •bolic conditions
- •9. Epilepsia
- •10. Hypotension (RRsys seated <= 100 mmHg and/or RRdia seated <= 60 mmHg)
- •11. HIV-positive patients
- •12. Active hepatitis B and/or hepatitis C
- •13. Pregnant or breastfeeding patients
- •14. Unwillingness or unability to cooperate; foreseeable problems with follow-up;
- •psychiatric disorders; known current alcohol, drug, or substance abuse; legal in-
- •15. Concurrent involvement in other clinical trials, or involvement in another clinical
- •trial within 30 days prior to inclusion in this trial.
研究者
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