A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 421
- 试验地点
- 500
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Multiple myeloma (MM) is a cancer of the blood's plasma cells. 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 change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.
Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.
In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year 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 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
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance of <=
- •Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
- •Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
- •Serum M-protein >= 0.5 g/dL (>= 5 g/L).
- •Urine M-protein >= 200 mg/24 hours.
- •In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
- •Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
- •-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.
- •Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
排除标准
- •Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
- •Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
- •Central nervous system involvement of MM.
- •Has received B-cell maturation antigen (BCMA)-targeted therapy.
研究组 & 干预措施
Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
干预措施: Carfilzomib (Drug)
Etentamig
Participants will receive etentamig as a monotherapy.
干预措施: Etentamig (Drug)
Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
干预措施: Pomalidomide (Drug)
Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
干预措施: Selinexor (Drug)
Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
干预措施: Bortezomib (Drug)
Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
干预措施: Elotuzumab (Drug)
Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to Approximately 5 Years
ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.
Progression Free Survival (PFS)
时间窗: Up to Approximately 5 Years
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.
次要结局
- 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 6 Months)
- Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Up to Approximately 6 Months)
- Change from Baseline in Remaining Items in the EORTC QLQ-MY20(Up to Approximately 6 Months)
- Change from Baseline in Patient Global Impression of Change (PGIC)(Up to Approximately 6 Months)
- Overall Survival (OS)(Up to Approximately 5 Years)
- Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR(Up to Approximately 5 Years)
- 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 - Multiple Myeloma Module (EORTC QLQ-MY20)(Up to 6 Months)
- Time to Next Anti-lymphoma Therapy (TTNT)(Up to Approximately 5 Years)
- Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)(Up to Approximately 5 Years)
- Change in Rate of CR or Better (>=CR)(Up to Approximately 5 Years)
- Time to Response (TTR)(Up to Approximately 5 Years)
- Time-to-Progression (TTP)(Up to Approximately 5 Years)
- Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)(Up to Approximately 6 Months)
- Change from Baseline in Patient Global Impression of Severity (PGIS)(Up to Approximately 6 Months)
- Duration of Response (DOR)(Up to Approximately 5 Years)
- Number of Participants with Event-free Survival (EFS)(Up to Approximately 5 Years)
- Change from Baseline in Remaining Items in the EORTC QLQ-C30(Up to Approximately 6 Months)
- Number of Participants with Skeletal-Related Event (SRE)(Up to Approximately 5 Years)
- Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)(Up to Approximately 6 Months)