A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 19
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells [WBCs] called plasma cells) for whom stem cell transplant is not planned as initial therapy.
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
- •Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria
- •Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or iii. deferral of high-dose chemotherapy with ASCT as initial treatment
- •Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2
- •Must sign an informed consent form (ICF)
- •Measurable disease at screening as assessed by central laboratory as defined in the protocol
排除标准
- •Myeloma Frailty Score of greater than or equal to (>=) 2 with the exception of participants who have a score of 2 based on age alone
- •Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients
- •Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial
- •Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM
- •Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids
研究组 & 干预措施
Arm B: Investigator's Choice (DVRd or DRd)
Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.
干预措施: Dexamethasone (Drug)
Arm B: Investigator's Choice (DVRd or DRd)
Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.
干预措施: Bortezomib (Drug)
Arm B: Investigator's Choice (DVRd or DRd)
Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.
干预措施: Lenalidomide (Drug)
Arm B: Investigator's Choice (DVRd or DRd)
Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.
干预措施: Daratumumab (Drug)
Arm A: Ramantamig plus Daratumumab (Ramantamig-D)
Participants will receive ramantamig D subcutaneous injection.
干预措施: Ramantamig (Drug)
Arm A: Ramantamig plus Daratumumab (Ramantamig-D)
Participants will receive ramantamig D subcutaneous injection.
干预措施: Daratumumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 62 months
PFS is defined as the time from treatment assignment (that is, randomization in the trial) to confirmed progression of disease (PD) or death, whichever occurs first.
Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response CR
时间窗: Up to 12 months
12-month MRD-negative CR rate is defined as achieving MRD-negative status at the analysis time window of 12 months (+/-3 months), as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, CR or better must be achieved any time from randomization up to and including 12+3 months, according to international myeloma working group (IMWG) criteria.
次要结局
- Percentage of Participants with Overall Response(Up to 5 years)
- Percentage of Participants with Overall MRD-Negative CR(Up to 5 years)
- Percentage of Participants with 12-Month Sustained MRD-Negative CR(Up to 5 years)
- Progression Free Survival After Subsequent Therapy (PFS2)(Up to approximately 100 months)
- Overall Survival (OS)(Up to approximately 100 months)
- Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR(Up to 5 years)
- Percentage of Participants with Very Good Partial Response (VGPR) or Better(Up to 5 years)
- Percentage of Participants with CR or Better(Up to 5 years)
- Number of Participants with Adverse Events (AEs)(Up to approximately 100 months)
- Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score(Baseline up to approximately 100 months)
- Change from Baseline in HRQoL as Assessed by EORTC-QLQ-C30 Scale Score(Baseline up to approximately 100 months)
- Change from Baseline in HRQoL as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score(Baseline up to approximately 100 months)
- Change from Baseline in HRQoL as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score(Baseline up to approximately 100 months)
- Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46(Baseline up to approximately 100 months)
- Percentage of Participants with Tolerability to Ramantamig-D Measured Through Patient Reported Outcomes (PROs)(Up to approximately 100 months)