A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 283
- 试验地点
- 49
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig
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 safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity 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. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide.
Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-day cycles.
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 side effects.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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 <= 2.
- Must have confirmed diagnosis 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) criteria.
- Must have measurable disease as determined by central lab as outlined in the protocol.
- Must be naïve to treatment with Etentamig.
- Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
- Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
- Arm E: Participant has received 1-3 prior lines of MM treatment.
排除标准
- Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
- Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
- Has any of the following conditions:
- Nonsecretory Multiple Myeloma (MM).
- Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
- Waldenstrom's macroglobulinemia.
- Light chain amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
- Major surgery within 4 weeks prior to first dose or planned study participation.
- Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
- Uncontrolled diabetes or hypertension within 14 days prior to first dose.
- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
研究组 & 干预措施
Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
干预措施: Dexamethasone (Drug)
Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
干预措施: Dexamethasone (Drug)
Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
干预措施: Daratumumab (Drug)
Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
干预措施: Etentamig (Drug)
Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
干预措施: Etentamig (Drug)
Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
干预措施: Pomalidomide (Drug)
Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
干预措施: Dexamethasone (Drug)
Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
干预措施: Dexamethasone (Drug)
Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
干预措施: Pomalidomide (Drug)
Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
干预措施: Etentamig (Drug)
Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
干预措施: Lenalidomide (Drug)
Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
干预措施: Etentamig (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig
时间窗: Up to approximately 28 Days
DLT events as described in the protocol will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately 3 Years
An AE 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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
次要结局
- Progression-Free Survival (PFS)(Up to Approximately 3 Years)
- Duration of Response (DOR)(Up to Approximately 3 Years)
- Time-to-Progression (TTP)(Up to Approximately 3 Years)
- Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)(Up to Approximately 3 Years)
- Overall Response Rate (ORR)(Up to Approximately 3 Years)
研究者
研究点 (49)
标识符
- NCT 编号
- NCT05259839
- 其他研究编号
- M22-947, 2023-506871-88-00
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (6年后)
- 研究完成日期
- (6年后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否