Daratumumab Infusion Acceleration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Total Daratumumab Infusion Time
研究概览
简要总结
This phase II trial studies the side effects and how well daratumumab works in treating patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of decreasing the infusion time of daratumumab in patients that have already received 2+ doses of daratumumab and are continuing on daratumumab.
II. Estimate the time savings versus (vs) predicted infusion time.
OUTLINE:
Patients receive daratumumab intravenously (IV) over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have received >= 2 daratumumab infusions and be scheduled to receive another dose
- •All races and ethnic groups are eligible for this study
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- •Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
研究组 & 干预措施
Treatment (daratumumab)
Patients receive daratumumab IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Daratumumab (Biological)
结局指标
主要结局
Total Daratumumab Infusion Time
时间窗: Up to 6 months
The start and stop times of daratumumab infusion will be tracked during infusion acceleration.
次要结局
- Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)(Up to 6 months)
- Infusion-related Reactions (IRR)(Up to 6 months)