EUCTR2005-004948-31-DE进行中（未招募）不适用
Bortezomib as consolidation therapy in patients aged 60 years and younger with multiple myeloma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Patients aged between 18 and 60 years or who have been participated in study
- •26866138MMY2031 (EudraCT-No 2005-003902-27)
- •2. Pretreatment with induction therapy and following single or tandem HD-CT and
- •autologous or allogenic stemcell transplantation in first line therapy (end of
- •therapy at least 60 and maximum 120 days back)
- •3. No disease progression after HD-CT
- •4. Existence of patient’s written informed consent
- •5. Women must be either post-menopausal for 2 years minimum, hysterectomized,
- •or have had a tubal ligation; patients of childbearing potential must:
- •a) use a safe method of contraception during treatment and for 6 months after
- •b) have a negative pregnancy test at time of screening
- •6. Male patients must use a reliable method of contraception during treatment and
- •up to 3 months after completion of treatment
- •7. Karnofsky status of 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. Creatinine clearance > 30 ml/min
- •11. Adjusted serum calcium < 14 mg/dl (3.5 mmol/l)
- •12. Adequate haematological functions:
- •- leucocytes 3.0 x 109/l or more
- •- neutrophils 1.5 x 109/l or more
- •- platelets 75 x 109/l or more
- •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. Nonsecretory multiple myeloma
- •2. Known allergic reaction to bortezomib, 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 NCI-CTCAE grade 2 or more
- •6. Epilepsia
- •7. 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); ECG evidence of
- •acute ischaemia; conduction disorders; cardiac amyloidosis
- •c) Systemic infection requiring treatment
- •d) Poorly controlled hypertension or other clinically relevant vascular
- •e) Poorly controlled diabetes mellitus or other clinically relevant endocrine or
- •metabolic conditions
- •f) severe coagulation disorder
- •8. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg)
- •10. Active hepatitis B and/or hepatitis C
- •11. Acute diffuse infiltrative pulmonary disease and pericardial disease
- •12. HB < 8 g/dl
- •13. Unwillingness or unability to cooperate; foreseeable problems with follow-up;
- •psychiatric diseases; known current alcohol, drug, or substance abuse; legal
- •14. Concurrent involvement in another clinical trial, or involvement in another clinical
- •trial within 30 days prior to inclusion in this trial
研究者
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