Bortezomib as consolidation therapy in patients aged 61-75 years with multiple myeloma

JANSSEN-CILAG GmbH0 个研究点目标入组 190 人开始时间: 2006年11月2日最近更新: 2015年2月2日

适应症

试验速览

暂无简介。

•1. Patients aged between 61 and 75 years
•2. Pretreatment with single- or tandem-HD-CT and autologous stemcell trans-
•plantation in first line therapy (end of therapy at least 60 and maximum 120
•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 70% 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) yes
•F.1.3.1 Number of subjects for this age range

•1. Nonsecretory multiple myeloma
•2. Previous allogenic stemcell transplantation
•3. Known allergic reaction to bortezomib, boron or mannitol
•4. Life expectancy of less than 3 months
•5. Malignant neoplasia (except basalioma) within the past 5 years
•6. Peripheral neuropathy of NCI-CTCAE grade 2 or more
•7. Epilepsia
•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
•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 conditions
•e) Poorly controlled diabetes mellitus or other clinically relevant endocrine or
•metabolic conditions
•9. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg)
•11. Active hepatitis B and/or hepatitis C
•12. Acute diffuse infiltrative pulmonary disease and pericardial disease
•13. Unwillingness or unability to cooperate; foreseeable problems with follow-up;
•psychiatric diseases; known current alcohol, drug, or substance abuse; legal
•15. Concurrent involvement in another clinical trial, or involvement in another clinical
•trial within 30 days prior to inclusion in this trial;

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