NCT07518186招募中3 期
A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 152
- 主要终点
- Complete Response (CR) or Better
研究概览
简要总结
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
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) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
- •Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
- •Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
- •Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
排除标准
- •Major surgery, (for example, requiring general anesthesia) or 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 study
- •Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
- •Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
- •Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
研究组 & 干预措施
Arm A: JNJ-79635322
Experimental
Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
干预措施: JNJ-79635322 (Drug)
Arm B: Teclistamab
Active Comparator
Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.
干预措施: Teclistamab (Drug)
结局指标
主要结局
Complete Response (CR) or Better
时间窗: Up to approximately 41 months
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.
Progression-Free Survival (PFS)
时间窗: Up to approximately 41 months
PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
次要结局
- Overall Response Rate (ORR)(Up to approximately 41 months)
- Very Good Partial Response (VGPR) or Better(Up to approximately 41 months)
- Duration of Response (DoR)(Up to approximately 41 months)
- Minimal Residual Disease (MRD)-negative CR(Up to approximately 41 months)
- MRD-negative CR at 1 Year(At 1 Year)
- MRD-negative CR at 5 Years(At 5 Years)
- Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)(Up to approximately 41 months)
- Overall Survival (OS)(Up to approximately 41 months)
- Time To Next Line of Therapy (TTNT)(Up to approximately 41 months)
- Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity(Up to approximately 41 months)
- Number of Participants with Abnormalities in Laboratory Parameters(Up to approximately 41 months)
- Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores(From Baseline up to approximately 41 months)
- Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores(From Baseline up to approximately 41 months)
- Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores(From Baseline up to approximately 41 months)
- Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores(Up to approximately 41 months)
- Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores(Up to approximately 41 months)
- Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores(Up to approximately 41 months)
- Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores(Up to approximately 41 months)
- Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores(Up to approximately 41 months)
- Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores(Up to approximately 41 months)
- Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46(Up to approximately 41 months)
研究者
研究点 (152)
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