A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 试验地点
- 66
- 主要终点
- Safety Run-In: Number of Participants With Adverse Events (AE)s
研究概览
简要总结
Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide.
Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide.
Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 relapsed or refractory (RR) multiple myeloma (MM).
- •Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
- •Adequate organ function and performance status
排除标准
- •Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
- •Known central nervous system involvement of MM
- •Known history of other active malignancies within the past 3 years (with specific exceptions)
- •Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)
结局指标
主要结局
Safety Run-In: Number of Participants With Adverse Events (AE)s
时间窗: Up to Approximately 75 Months
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
时间窗: Up to Approximately 75 Months
CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria. CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates. The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).
Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
时间窗: Up to Approximately 75 Months
PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.
次要结局
- Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment(Up to Approximately 75 Months)
- Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig(Up to Approximately 12 Months)
- Safety Run-In: Time to Cmax (Tmax) of Etentamig(Up to Approximately 12 Months)
- Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig(Up to Approximately 12 Months)
- Safety Run-In: Immunogenicity of Etentamig(Up to Approximately 75 Months)
- Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: Overall Survival (OS)(Up to Approximately 75 Months)
- Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity(Up to Approximately 75 Months)
- Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: BOR Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: VGPR or Better Rate Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: Time to Response (TTR) Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: Duration of Response (DOR) Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: Second Progression-Free Survival (PFS2)(Up to Approximately 75 Months)
- Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (QoL) Score(Up to Approximately 75 Months)
- Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment(Up to Approximately 75 Months)
- Randomized Portion: Time to Next Treatment (TTNT)(Up to Approximately 75 Months)
- Randomized Portion: Time to Symptomatic Disease Progression(Up to Approximately 75 Months)
- Randomized Portion: Change From Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma Module (EORTC QLQ-MY20)(Up to Approximately 75 Months)
- Randomized Portion: Change From Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Up to Approximately 75 Months)
- Randomized Portion: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 (FACT-G GP5)(Up to Approximately 75 Months)