CTRI/2011/05/001732已完成3 期
An Open-Label, Randomized Study of Subcutaneous and IntravenousVELCADE in Subjects With Previously Treated Multiple Myeloma - 26866138MMY3021
Johnson and Johnson Limited0 个研究点目标入组 222 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female subjects 18 years or older
- •Diagnosis of multiple myeloma based on the standard criteria described in Attachment 1.
- •3. Measurable, secretory multiple myeloma defined as a serum monoclonal IgG of ≥10 g/L or a serum monoclonal IgA, IgD,or IgE
- •≥5 g/L, or urine M-protein of ≥200 mg/24 hr
- •4. Relapse or progression of myeloma following prior systemic antineoplastic therapy. Relapse or progression is defined by any of the following:
- •? Reappearance of measurable disease (as defined above) following
- •? ≥25% increase in serum or urine M-protein
- •? Development of new or worsening lytic bone disease
- •? New plasmacytomas or ≥50% increase in the longest dimension of
- •an existing plasmacytoma
- •? Worsening hypercalcemia (corrected serum Ca 11.5 mg/dL
- •[2.8 mmol/L]) due to multiple myeloma
- •5. Karnofsky performance status ≥70% (Attachment 2)
- •6. Platelet count ≥50 x 109/L without transfusion support within 7 days
- •before the laboratory test
- •7. Hemoglobin ≥8 g/dL (≥4.96 mmol/L) without transfusion support
- •within 7 days before the laboratory test.
- •8. Absolute neutrophil count (ANC) ≥0.75 x 109/L.
- •9. Corrected serum Ca 14 mg/dL (3.5 mmol/L)
- •10. Aspartate aminotransferase (AST) ≤2.5X upper limit of normal (ULN)
- •11. Alanine aminotransferase (ALT) ≤2.5X ULN
- •12. Total bilirubin ≤1.5X ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome)
- •13. Creatinine clearance ≥20 mL/min, calculated using the formula
- •14. Toxic effects of previous therapy or surgery have resolved to CTCAE Grade 1 or better
- •15. Women who are not post-menopausal or surgically sterile must have a negative pregnancy test and agree to use an acceptable method of birth control during the study until 30 days after the last dose of study drug.
- •16. Men must agree to not father a child and agree to use a latex condom during treatment and for 30 days after the last dose of study drug,
- •even if they have had a successful vasectomy, if their partners are of childbearing potential.
- •17. Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn
- •by the subject at any time without prejudice to future medical care.
排除标准
- •1. Previous treatment with VELCADE
- •2. More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a 6 month treatment-free interval)
- •3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ¡Ý2
- •4. Any of the following within 3 weeks prior to randomization:antineoplastic or experimental therapy, corticosteroid use above10 mg/day (prednisone or equivalent), or plasmapheresis
- •5. Any of the following within 2 weeks prior to randomization: radiation therapy, major surgery (kyphoplasty is not considered major surgery)
- •6. Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected
- •carcinoma in situ or basal/squamous carcinoma of the skin.
- •7. Myocardial infarction within 6 months prior to enrollment 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 clinically
- •significant conduction system abnormalities
- •8. Concurrent medical condition or disease (e.g., active systemic
- •infection, uncontrolled diabetes, therapeutic use of anticoagulants)that is likely to interfere with study procedures or results (including local injection tolerability), that in the opinion of the investigator would constitute a hazard for participating in this study
- •9. History of allergic reaction attributable to compounds containing boron or mannitol
研究者
相似试验
进行中（未招募）
不适用
An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple MyelomaEUCTR2008-000952-28-GBJanssen-Cilag International NV (JCI)216
进行中（未招募）
1 期
An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple MyelomaThe subject population comprises adult male and female subjects with multiple myeloma that has relapsed or progressed after prior systemic antineoplastic therapy, presence of measurable secretory disease, Karnofsky performance status score greater than or equal to 70%, and clinical hematology and chemistry laboratory values that meet predefined criteria.MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2008-000952-28-FRJanssen-Cilag International NV (JCI)
进行中（未招募）
不适用
An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple MyelomaThe subject population comprises adult male and female subjects with multiple myeloma that has relapsed or progressed after prior systemic antineoplastic therapy, presence of measurable secretory disease, Karnofsky performance status score greater than or equal to 70%, and clinical hematology and chemistry laboratory values that meet predefined criteriaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2008-000952-28-BEJanssen-Cilag International NV (JCI)216
尚未招募
3 期
An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple MyelomaNL-OMON32310Janssen-Cilag10
进行中（未招募）
不适用
An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple MyelomaThe subject population comprises adult male and female subjects with multiple myeloma that has relapsed or progressed after prior systemic antineoplastic therapy, presence of measurable secretory disease, Karnofsky performance status score greater than or equal to 70%, and clinical hematology and chemistry laboratory values that meet predefined criteriaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2008-000952-28-DEJanssen-Cilag International NV (JCI)216