A Phase 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 28
- 主要终点
- Safety and tolerability of cemsidomide in combination with elranatamab
研究概览
简要总结
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.
The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.
Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Diagnosis of multiple myeloma as defined by IMWG criteria
- •Measurable disease based on IMWG criteria
- •Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader)
- •ECOG performance status 0-2
排除标准
- •Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
- •Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- •Participants with any active, uncontrolled bacterial, fungal, or viral infection
- •Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
- •Administration with an investigational product within 30 days preceding the first dose of study intervention
- •Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
研究组 & 干预措施
Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection)
干预措施: Cemsidomide (Drug)
Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection)
干预措施: Elranatamab (Biological)
结局指标
主要结局
Safety and tolerability of cemsidomide in combination with elranatamab
时间窗: Baseline through 30 days after discontinuation of study treatment
Frequency and severity of AEs
Safety and tolerability of cemsidomide in combination with elranatamab
时间窗: Cycle 1 approximately 28 days
Dose limiting toxicity rate
次要结局
- Assess antimyeloma activity(Approximately 2 years)
- Evaluate the PK of cemsidomide and elranatamab(Approximately 2 years)
- Assess the immunogenicity of elranatamab(Approximately 2 years)
- Evaluate the PK of cemsidomide and elranatamab(Approximately 4 months)