A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 73
- 主要终点
- Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])
研究概览
简要总结
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C & D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C & D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world.
Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.
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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
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
- •Must have measurable disease as outlined in the protocol.
- •Eastern Cooperative Oncology Group (ECOG) performance of <=
- •Arm C and Arm D: ECOG performance of <=
- •Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
- •Must be naïve to treatment with etentamig (ABBV-383).
- •Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
- •Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] directed against BCMA).
- •Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
- •Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
排除标准
- •Arm A: Received BCMA-targeted therapy.
- •Arm C and Arm D: Rapidly progressing disease per investigator.
研究组 & 干预措施
Arm A (Part 1): ABBV-383 Dose Escalation
B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.
干预措施: Etentamig (ABBV-383) (Drug)
Arm A (Part 2): ABBV-383 Dose Expansion
BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
干预措施: Etentamig (ABBV-383) (Drug)
Arm B: ABBV-383 BCMA Exposed
Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
干预措施: Etentamig (ABBV-383) (Drug)
Arm C: ABBV-383 Step Up
Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
干预措施: Etentamig (ABBV-383) (Drug)
Arm D: ABBV-383 Step Up
Participants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
干预措施: Etentamig (ABBV-383) (Drug)
结局指标
主要结局
Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])
时间窗: Up to Day 28
AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
时间窗: Up to Day 28
CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
次要结局
- Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events(Up to 3 Years)