EUCTR2008-003213-27-DE进行中（未招募）不适用
Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone with or without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma - VelKom
ORTHO BIOTECH, Division of JANSSEN-CILAG GmbH0 个研究点开始时间: 2008年8月25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
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 or female =18 years of age
- •2. Informed consent
- •3. Diagnosis of multiple myeloma and measurable disease (serum M-protein
- •=1g/dL (10g/L, urine light-chain excretion =200mg/24h, involved FLC level
- •=10mg/dL provided sFLC ratio is abnormal)
- •4. Relapse or refraction of multiple myeloma following 1-3 previous lines of therapy and requires treatment. The subject has undergone or is not eligible for bone marrow transplantation.
- •5. Karnofsky status =60%
- •6. Life expectancy estimated at screening of at least 6 months
- •7. Willingness or ability to comply in the investigator's opinion
- •8. Women must be postmenopausal or surgically sterilized; women of childbearing
- •potential must use a safe method of contraception before entry and throughout
- •the study and have a negative pregnancy test at screening. Accepted is also a
- •male partner vasectomized
- •9. Male patients must use a reliable method of contraception from screening up to
- •6 months after trial completion.
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •1. More than three previous lines of therapy for multiple myeloma
- •2. Known allergy or hypersensitivity to bortezomib, dexamethasone and/or cyclo-
- •phosphamide or to any of the constituent compounds containing boron, mannitol,
- •3. Progressive disease or stable disease under bortezomib in a previous line of
- •4. Oligosecretory or non-secretory multiple myeloma
- •5. Reception of nitrosoureas or any other chemotherapy within 6 weeks before
- •6. Reception of corticosteroids (>10 mg/day prednisone or equivalent) within 3
- •weeks before enrolment
- •7. Immunotherapy or antibody therapy for multiple myeloma within 8 weeks
- •before enrolment (Ig substitution therapy is not excluded)
- •8. Plasmapheresis within 2 weeks before enrolment
- •9. Major surgery within 4 weeks before enrolment (kyphoplasty is not considered
- •major surgery)
- •10. Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as
- •defined by NCI CTCAE, version 3.0
- •11. Uncontrolled or severe cardiovascular disease, including myocardial infarction
- •within 6 months before enrolment or NYHA Class III or IV heart failure, uncon-
- •trolled angina, acute diffuse infiltrative pulmonary and pericardial disease,
- •severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
- •acute ischemia, active conduction system abnormalities or cardiac amyloidosis
- •12. Clinically relevant or poorly controlled vascular, pulmonary, gastrointestinal,
- •endocrine, neurological, psychiatric or metabolic diseases, which could potentially
- •interfere with the completion of treatment according to protocol
- •subject has urinary tract obstruction or cystitis before start of therepy
- •Subject has liver or renal insufficiency indicated by one or more of the following
- •pre-treatment laboratory values within 14 days before and at baseline:
- •· platelet count < 50×109/L (transfusion support within 14 days before the test
- •is not allowed)
- •· haemoglobin = 7,5 g/dL
- •· calculated or measured creatinine clearance < 20 mL/min
- •· absolute neutrophil count (ANC) < 0,75×109/L (the use of colony stimulating
- •factors within 14 days before the test is not allowed)
- •· adjusted serum calcium =14 mg/dL (3,5 mmol/L)
- •· aspartate transaminase (AST) > 2,5 × the upper limit of normal (ULN)
- •· alanine transaminase (ALT) > 2,5 × ULN
- •· total bilirubin > 1,5 × ULN
- •13. Malignancy other than multiple myeloma within 5 years before enrolment:
- •Exceptions for the following if treated and not active: basal cell or nonmetastatic
- •squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 of
- •14. HIV positive status. When assessed by the investigator to be at risk for HIV
- •testing in accordance with local policies
- •15. Positive status of hepatitis B surface antigen or known active hepatitis C. When
- •assessed by the investigator to be at risk for hepatitis B or C testing in
- •accordance with local regulations
- •16. Systemic infection requiring treatment
- •17. Use of disallowed concomitant medication
- •18. Participation in other clinical studies conducted in parallel and participation in a
- •clinical study, i.e. subject has received an experimental drug or used an ex-
- •perimental medical device, within 30 days prior to enrolment in this study. This
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