EUCTR2005-003902-27-DE进行中（未招募）不适用
Clinical trial on induction of remission with bortezomib (Vel), cyclophosphamide (C) and dexamethasone (D) in patients until the age of 60 with untreated multiple myeloma and planned high dosage chemotherapy: (VelCD), (DSMM XIa)
ORTHO BIOTECH, Division of JANSSEN-CILAG GmbH0 个研究点目标入组 400 人开始时间: 2005年11月8日最近更新:
适应症
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
- 400
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 patients between 18 and 60 years of age
- •2. Multiple myeloma of stages II or III (Durie and Salmon). Patients requiring treat-
- •ment are classified as follows:
- •- Hypercalcaemia (serum calcium level > 0,25 mml/l above the upper limit
- •of normal or > 2,5 mmol/l)
- •- Renal impairment
- •- Serum creatinine > 173 mm0l/l
- •- Anaemia (haemoglobin 2g/dl below the laboratory specific normal value
- •or < 10 g/dl)
- •- Osseous changes (lytic lesions or osteoporosis with compression
- •3. Study part 1: Patients without cytostatic pretreatment designed for an induction
- •therapy with cyclophosphamide and dexamethasone (a radiotherapeutic pre-
- •treatment is allowed as well as a pretreatment with dexamethasone in patients
- •with renal insufficiency)
- •Study part II: Patients without cytostatic pretreatment designed for an induction
- •therapy with cyclophosphamide and dexamethasone (a radiotherapeutic pre-
- •treatment is allowed as well as a pretreatment with dexamethasone)
- •4. Existence of patient’s written informed consent
- •5. Women must be postmenopausal or sterilized; patients of childbearing potential
- •must use a safe method of contraception during treatment and for 6 months after
- •completion and have a negative pregnancy test at the time of screening
- •6. Male patients must use a reliable method of contraception during treatment and
- •up to 6 months after completion.
- •7. Karnofsky status 60% or more
- •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 haematological functions:
- •- Leukocytes more than 3.0 x 109/l
- •- Neutrophils more than 1.5 x 109/l
- •- Platelets more than 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Non-secretory multiple myeloma
- •2. Known allergic reaction to bortezomib, cyclophosphamide, boron, or mannitol
- •3. Life expectancy of less than 3 months
- •4. Malignant neoplasia (except basalioma) within the past 5 years
- •5. Peripheral neuropathy of CTC grade 2 or more
- •6. 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
- •b) Cardiac failure > NYHA II; myocardial infarction within 6 months prior to
- •screening; pectoral angina; cardiac arrhythmia (Lown IVb or more);
- •ECG evidence of acute ischaemia; conduction disorders; cardiac amyloidosis
- •c) Systemic infection requiring treatment
- •d) Poorly controlled hypertension or other clinically relevant vascular diseases
- •e) Poorly controlled diabetes mellitus or other clinically relevant endocrine or
- •metabolic diseases
- •7. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg)
- •8. HIV-positive status
- •9. Active hepatitis B and/or hepatitis C
- •10. Acute diffuse infiltrative pulmonary and pericardial disease
- •11. Pregnancy or breastfeeding period
- •12. Unwillingness or unability to cooperate; foreseeable problems with follow-up;
- •psychiatric diseases; known current alcohol-, drug-, or substance abuse; legal
- •13. Current participation in another clinical trial or participation in a drug examination
- •within the last 30 days before inclusion in this clinical trial
研究者
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