NL-OMON32310尚未招募3 期
An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma - Velcade Sub Q study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
- •- 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 CR
- •· >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
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 ³2
研究者
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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）
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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
进行中（未招募）
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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
已完成
3 期
Velcade is being tested in Subcutaneus route as compared to Intravenous route in pateitns with previuosly treated Multiple MyelomaCTRI/2011/05/001732Johnson and Johnson Limited222