NCT07284758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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 21
- 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
This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
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
- •Be willing and able to provide signed informed consent for the study.
- •Age ≥ 18 years at the time of signed consent.
- •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.
- •Subjects need to have adequate organ function.
- •Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ 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 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.
- •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.
- •Uncontrolled active bacterial, fungal, or viral infection.
- •Inability or difficulty swallowing tablets.
- •NOTE: Other inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Cemsidomide + Dexamethasone:
Experimental
Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria.
干预措施: Cemsidomide (Drug)
Cemsidomide + Dexamethasone:
Experimental
Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria.
干预措施: Dexamethasone (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)
时间窗: up to approximately 43 months
次要结局
- Duration of response (DoR; IRC assessed)(up to approximately 43 months)
- Complete response (CR) rate (IRC assessed)(up to approximately 43 months)
- Time to response (IRC assessed)(up to approximately 43 months)
- Progression free survival (PFS; IRC assessed)(up to approximately 43 months)
- Overall survival (OS)(up to approximately 43 months)
- Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths(within 30 to 35 days of the last dose of study treatment)
- Plasma concentrations of cemsidomide(up to approximately 4 months)
研究者
研究点 (21)
Loading locations...
相似试验
尚未招募
1 期
Study of TYK-01054 Capsules in Patients With Advanced Solid TumorsNCT07282873TYK Medicines, Inc219
招募中
1 期
A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast CancerNCT07281976Nanjing Leads Biolabs Co.,Ltd220
进行中（未招募）
1/2 期
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anticancer agents in patients with HER2-positive Metastatic Breast Cancer inclusive of patients with active and stable brain metastases2023-505309-18-00AstraZeneca AB46
招募中
1 期
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal TumorsNCT07263594DualityBio Inc.127
尚未招募
2 期
A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung CancerNCT07283198Jiangsu Alphamab Biopharmaceuticals Co., Ltd160