Safety of Rapid-Infusion Isatuximab in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Number of participants with reported grade 2 or higher infusion-related reactions (IRR)
研究概览
简要总结
This phase II trial studies the effects of isatuximab given as a rapid-infusion in treating multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory). Isatuximab, also known as Sarclisa, is an antibody (proteins that can protect the body from foreign organisms, such as bacteria and viruses) directed against cluster of differentiation 38 (CD38), a receptor antigen (a receptor or protein on the outside of blood cells that can be used as a target). Isatuximab may stop the growth of some blood cancers. Normally, the fastest that intravenous isatuximab can be given - for patients who have not had any reactions to their first two doses - is over 1 hour and 15 minutes. This study is designed to test whether intravenous isatuximab can be given over 30 minutes ("rapid infusion") among patients who have not developed any reactions to at least 2 prior doses of intravenous isatuximab at normal speeds. If shown to be safe, "rapid infusion" isatuximab may ultimately improve the patient experience while reducing the overall cost of the infusion.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the incidence of grade 2 or higher (Gr2+) infusion-related reactions (IRRs) with rapid-infusion (RI) isatuximab across 6 doses.
SECONDARY OBJECTIVE:
I. To estimate time savings with RI isatuximab (versus estimated standard of care [SOC] isatuximab duration lengths) across 6 doses of isatuximab.
OUTLINE:
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
- •Histologically confirmed diagnosis of multiple myeloma (International Classification of Disease (ICD-10) code: C90.0)
- •Previous exposure to at least one proteasome inhibitors (PI) and lenalidomide (or candidacy for isatuximab as per updated Food and Drug Administration (FDA) package insert information in the future)
- •Planned or current isatuximab-containing therapy. Patients receiving isatuximab as part of a clinical trial are eligible for this study if allowed by the trial sponsor.
- •For ease of registration, patients will be allowed to enroll at any point after the decision is made to initiate isatuximab (with the understanding that their initial doses will be standard of care (SOC), including the first 2 doses for all patients). However, rapid infusion (RI) isatuximab will only be administered to participants who have not had infusion-related reactions (iRRs) during >= 2 consecutive prior doses of SOC isatuximab
- •Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document
排除标准
- •Age < 18
- •Body weight > 70 kilograms (kg) at the time of any RI isatuximab dose
- •Current pregnancy or (if of reproductive age) unwillingness to follow contraception requirements as per the FDA package insert
- •New York Heart Association Stage IV heart disease, i.e. unable to carry on any physical activity without discomfort or symptoms of heart failure (as per study investigator)
- •Any medical condition, including mental illness or substance abuse, deemed by the principal investigator to interfere with the ability to provide consent or cooperate with study procedures
结局指标
主要结局
Number of participants with reported grade 2 or higher infusion-related reactions (IRR)
时间窗: Up to 6 months
The per-patient incidence of Grade 2 or higher IRRs with rapid infusion (RI) isatuximab will be calculated as the number of patients who developed \>= 1 Grade 2+ IRR with RI isatuximab divided by the total number of patients who receive \>= 1 dose of RI isatuximab.
次要结局
- Mean per-participant infusion duration(9-12 weeks depending on isatuximab dosing interval)
研究者
Thomas Martin, MD
Principal Investigator
University of California, San Francisco