Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 49
- 主要终点
- Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
研究概览
简要总结
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.
Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.
In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.
详细描述
B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance of 0 or
- •Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
- •All participants must have measurable diseases per central laboratory as outlined in protocol
排除标准
- •Has received prior etentamig treatment.
- •Prior exposure to BCMA-targeted therapy as noted in the protocol.
- •Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
研究组 & 干预措施
Phase 1: ABBV-383 Dose Escalation
In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
干预措施: Etentamig (Drug)
Phase 1: ABBV-383 Dose Escalation
In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
干预措施: Iberdomide (Drug)
Phase 2: ABBV-383 Dose Expansion Dose A
In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
干预措施: Etentamig (Drug)
Phase 2: ABBV-383 Dose Expansion Dose A
In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
干预措施: Iberdomide (Drug)
Phase 2: ABBV-383 Dose Expansion Dose B
In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
干预措施: Etentamig (Drug)
Phase 2: ABBV-383 Dose Expansion Dose B
In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
干预措施: Iberdomide (Drug)
结局指标
主要结局
Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
时间窗: Up to Approximately 56 Days
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Number of Participants with Adverse Events (AE)s
时间窗: Up to Approximately 129 Months
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Partial Response (PR) Response Rate (RR)(Up to 3 Years)
- Very Good Partial Response (VGPR) RR(Up to 3 Years)
- Complete Response (CR) RR(Up to 3 Years)
- Stringent Complete Response (sCR) RR(Up to 3 Years)
- Overall Response Rate (ORR)(Up to 3 Years)
- Progression-Free Survival (PFS)(Up to 3 Years)
- Duration of Response (DOR)(Up to 3 Years)
- Time-to-Progression (TTP)(Up to 3 Years)
- Minimal Residual Disease (MRD) negativity(Up to 3 Years)