EUCTR2020-003024-16-IT进行中（未招募）1 期
Phase 1-2 trial evaluating anti-TGFß agent (SAR439459) or pomalidomide in combination with isatuximab and dexamethasone in relapsed or refractory multiple myeloma (RRMM) - .
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 60 人开始时间: 2021年6月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Participants who have received at least 3 prior lines of therapy for Multiple myeloma or at least 2 prior lines if at least one of these lines consisted of 2 or more multiagent regimens. Prior exposure to drugs targeting CD38 is allowed with a wash-out of at least 6 months after the last dose.
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •-measurable disease.
- •-Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •-Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to randomization.
- •-Uncontrolled or active hepatitis B or C virus.
- •-Malabsorption syndrome.
- •-Any anti-MM drug treatment within 14 days before randomization, including dexamethasone.
- •-Inadequate organ functions.
- •-Corrected serum calcium >14 mg/dL (>3.5 mmol/L).
- •-Sensitivity to any of the study interventions.
- •-Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control.
研究者
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