2022-501522-38-00招募中3 期
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 11
- 主要终点
- Adverse event collection
研究概览
简要总结
To obtain long-term safety data for subjects from ongoing venetoclax studies
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subject has completed a prior venetoclax study, and the investigator believes that continued treatment with venetoclax is in the best interest of the patient.
- •Subjects are willing or able to comply with procedures required in this protocol.
- •Subjects entering the extension study with multiple myeloma must adhere to the following guidelines: • All subjects receiving treatment with venetoclax in combination with a proteasome inhibitor must receive prophylaxis with antibiotics while on treatment and for at least 30 days after discontinuation of the proteasome inhibitor and/or venetoclax including: Bactrim forte® (1 tablet, 3 times a week) or equivalent antibiotic therapy AND Amoxicillin clavulanate (500 mg to 1 g, twice daily) or levofloxacin (500 mg once daily, adjusted for renal function) or equivalent antibiotic therapy per institutional guidelines
- •Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Subjects agree to abide by protocol-mandated pregnancy avoidance measures.
排除标准
- •Female who is pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
- •Male who is considering fathering a child or donating sperm during the study and for approximately 90 days after the last dose of study drug.
- •Subjects receiving any live vaccines during study participation including until at least 4 weeks (for all indications except MM) and 8 weeks (for subjects with MM) after the last dose of study drug.
结局指标
主要结局
Adverse event collection
Adverse event collection
次要结局
未报告次要终点
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
研究点 (11)
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