2023-507180-19-00招募中2 期
International, multi-center, open-label, treatment extension study in patients with multiple myeloma who are still benefitting from isatuximab-based therapy following completion of a Phase 1, 2, or 3 parental study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 16
- 主要终点
- Number of participants with treatment-emergent adverse events
研究概览
简要总结
To assess the long-term safety of isatuximab administered as monotherapy or in combination regimens in participants previously treated with isatuximab
研究设计
- 研究类型
- Interventional
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
- •Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.
- •Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed.
- •Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included.
- •Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
- •Capable of giving signed informed consent.
排除标准
- •Participant has evidence of progressive disease during or at the time of the parental study closure.
- •Participant has not recovered to ≤Grade 2 from non-hematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study.
- •As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study.
- •Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- •Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
- •Any country-related specific regulation that would prevent the participant from entering the study.
结局指标
主要结局
Number of participants with treatment-emergent adverse events
Number of participants with treatment-emergent adverse events
次要结局
未报告次要终点
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Research & Development
研究点 (16)
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