2025-524181-26-00招募中2 期
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (r/r MM)
C4 Therapeutics Inc.28 个研究点 分布在 4 个国家目标入组 43 人开始时间: 2026年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 28
- 主要终点
- Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)
研究概览
简要总结
To determine antitumor activity of cemsidomide in combination with dexamethasone in subjects with r/r MM.
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
- 否
入选标准
- •Be willing and able to provide signed informed consent for the study.
- •Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.
- •Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
- •Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care. Participants should not be candidates for regimens known to provide clinical benefit or should have refused such treatment options
- •Subjects need to have adequate organ function.
- •Toxicities from prior anticancer therapies must have resolved to ≤ Grade
- •Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.
- •Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
- •Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
排除标准
- •Presence of myeloma in the central nervous system (CNS).
- •Subjects with any of the following: • Systemic light chain amyloidosis • Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome • Myelodysplastic syndrome (MDS).
- •Previously treated with cemsidomide.
- •Clinically significant impaired cardiac function or cardiac disease.
- •Thromboembolic event within 3 months prior to enrollment.
- •Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
- •Any active uncontrolled bacterial, fungal or viral infection.
- •Inability or difficulty swallowing tablets.
研究组 & 干预措施
Cemsidomide
Test
干预措施: Cemsidomide (Drug)
结局指标
主要结局
Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)
Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)
次要结局
- Overall survival
- Duration of response
- Complete response (CR) rate
- Time to response
- Progression free survival
- Frequency and severity of adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths
- Plasma concentrations of cemsidomide
研究者
Study Medical Officer
Scientific
C4 Therapeutics Inc.
研究点 (28)
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