EUCTR2006-001709-27-DE进行中（未招募）不适用
A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of Velcade® when added to Adriamycin-Dexamethasone Treatment versus Vincristine-Adriamycin-Dexamethasone Standard Treatment in Subjects with Multiple Myeloma who are Refractory to or Have Relapsed after Primary Therapy for Multiple Myeloma - PAD versus VAD in 2nd line 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）
- 入组人数
- 212
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 subject, aged 18 years and more.
- •2. The subject has given voluntary written informed consent before performance of
- •any study related procedure not part of normal medical care, with the under-
- •standing that consent may be withdrawn by the subject at any time without
- •prejudice to future medical
- •3. Subject was previously diagnosis of multiple myeloma based on standard criteria
- •and has measurable disease. Measurable disease for secretory multiple
- •myeloma is defined as any quantifiable serum monoclonal protein value
- •(generally, but not exclusively, greater than 1 g/dl of immunoglobulin G (IgG)
- •M-Protein and greater than 0,5 g/dl immunoglobulin A (IgA)) or urine light-chain
- •excretion of 200 mg or more in 24 hours.
- •4. The subject has relapsed or refractory multiple myeloma following 1 previous line
- •of therapy and scheduled by the investigator to be treated with vincristine,
- •adriamycin and dexamethasone (VAD) combination treatment. PD or relapse are
- •defined as one or more of the following criteria: Criteria for PD:
- •- >25% increase in either serum or urine M-protein.
- •- >25% increase in plasma cells on bone marrow.
- •- Definite increase in size of bone lesion or plasmacytoma.
- •- Development of new bone lesion or plasmacytoma.
- •- Development of hypercalcemia (corrected serum calcium >11,5 mg/dl or
- •2,8 mmol/l) not attributable to other causes.
- •Criteria for relapse from CR:
- •- Reappearance of serum or urinary paraprotein on immunofixation or routine
- •electrophoresis, confirmed by at least one further investigation and excluding
- •oligoclonal immune reconstitution.
- •- >5% plasma cells in bone marrow aspirate or on trephine bone biopsy.
- •- Development of new lytic bone lesions or soft tissue plasmacytomas or definite
- •increase in the size of residual bone lesions.
- •- Development of hypercalcemia (corrected serum calcium >11,5 mg/dl or
- •2,8 mmol/l) not attributable to any other cause.
- •5. Subject has a Karnofsky performance status of 60% or more.
- •6. Subject has a fife-expectancy at screening of at least 6 months.
- •7. The subject meets the following pretreatment laboratory criteria at and within 14
- •days before baseline (Day 1 of Cycle 1, before drug administration):
- •- Platelet count >=50 x 10 9/l.
- •- Hemoglobin of 7,5 g/dl or more without transfusion support within 7 days
- •before the test.
- •- Creatinine clearance 20 ml/minute or more .
- •- Absolute neutrophil count (ANC) >=0,75 x 10 9/l without the use of colony
- •stimulating factors.
- •- Adjusted serum calcium <14 mg/dl (3,5 mmol/l).
- •- Aspartate aminotransferase (AST) 2,5 x the upper limit of normal (ULN) or less.
- •- Alanine aminotransferase (ALT) 2,5 x the ULN or less.
- •- Total bilirubin 1,5 x the ULN or less.
- •8. The subject is , in the investigator's opinion, willing and able to comply with the
- •protocol requirements.
- •9. If female, the subject is either postmenopausal or surgically sterilised or willing
- •to use an acceptable method of birth control from screening through at least 30
- •days after completion of the last treatment cycle.
- •10. If male, the subject agrees to use an acceptable barrier method for contra-
- 另有 1 项未显示
排除标准
- •1. Subject received more than one previous line of therapy for multiple myeloma.
- •2. Subject has known allergy or hypersensitivity to bortezomib, boron or mannitol.
- •3. Use of Velcade in the previous line of therapy and/or the subject received
- •Velcade in a previous trial.
- •4. Subject has oligosecretory or non-secretory multiple myeloma.
- •5. Subject received nitrosoureas or any other chemotherapy (including
- •thalidomide), clarithromycin, interferon within 6 weeks.
- •6. Subject received corticosteroids (>10 mg/day prednisone or equivalent) within 3
- •weeks before enrolment.
- •7. Subject received immunotherapy or antibody therapy within 8 weeks before
- •8. Subject received plasmapheresis within 4 weeks before enrolment.
- •9. Subject had major surgery within 4 weeks before enrolment (kyphoplasty is not
- •considered major surgery).
- •10. Subject has peripheral neuropathy or neuropathic pain of grade 2 or greater
- •intensity, as defined by the National Cancer Institute Common Terminology
- •Criteria of Adverse Events (NCICTCAE), version 3.0.
- •11. Subject had a myocardial infarction within 6 months of enrolment or New York
- •Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe
- •uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
- •ischemia or active conduction system abnormalities.
- •12. Subject has poorly controlled hypertension, diabetes mellitus, or other serious
- •medical or psychiatric illness that could potentially interfere with the completion
- •of treatment according to this protocol.
- •13. Subject was treated for a cancer other than multiple myeloma within 5 years
- •before enrolment, with the exception of basal cell carcinoma or cervical cancer in
- •14. Subject is known to be human immunodeficiency virus (HIV)-positive. (Subjects
- •assessed by the investigator to be at risk for HIV infection should be tested in
- •accordance with local regulations.)
- •15. Subject was known to be hepatitis B surface antigen-positive or had known
- •active hepatitis C infection. (Subjects assessed by the investigator to be at risk
- •for hepatitis B or C infection are to be tested in accordance with local
- •regulations.)
- •16. Subject had an active systemic infection requiring treatment.
- •17. Subject uses disallowed medication.
- •18. Subject has received an experimental drug or used an experimental medical
- •device within 4 weeks before enrolment.
- •19. If female, the subject is pregnant or breast-feeding. Confirmation that the sub-
- •ject is not pregnant must be established by a negative serum pregnancy test at
- •screening. Pregnancy testing is not required for postmenopausal or surgically
- •sterilised women.
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