NCT07258511招募中3 期
A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody
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
- 400
- 试验地点
- 144
- 主要终点
- Overall Response
研究概览
简要总结
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
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:
- •MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
- •Measurable disease at screening as assessed by central laboratory
- •Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
- •Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria
- •Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
- •Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
排除标准
- •Active hepatitis of infectious origin
- •Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
- •Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
- •Major surgery, (example, requiring general anesthesia) within 2 weeks before 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
- •Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment
研究组 & 干预措施
JNJ-79635322
Experimental
Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.
干预措施: JNJ-79635322 (Drug)
Anti BCMAxCD3 Bispecific Antibody
Active Comparator
Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.
干预措施: Teclistamab (Drug)
结局指标
主要结局
Overall Response
时间窗: Up to 5 years and 7 months
Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
Progression-Free Survival (PFS)
时间窗: Up to 5 years and 7 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.
Overall Response Rate (ORR)
时间窗: Up to 5 years and 4 months
ORR is defined as the percentage of participants who achieve partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria.
Progression-Free Survival (PFS)
时间窗: Up to 5 years and 4 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
- Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322(Up to 5 years and 7 months)
- Very Good Partial Response (VGPR) or Better(Up to 5 years and 7 months)
- Complete Response (CR) or Better(Up to 5 years and 7 months)
- Duration of Response (DoR)(Up to 5 years and 7 months)
- Minimal Residual Disease (MRD)-negative CR(Up to 5 years and 7 months)
- MRD-Negative CR at 12 months(12 months)
- Sustained MRD-negative CR(Up to 5 years and 7 months)
- Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)(Up to 5 years and 7 months)
- Overall Survival (OS)(Up to 5 years and 7 months)
- Time to Subsequent Anti-Myeloma Therapy(Up to 5 years and 7 months)
- Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity(Up to 5 years and 7 months)
- Number of Participants with Abnormalities in Clinical Laboratories Results(Up to 5 years and 7 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score(Baseline up to 5 years and 7 months)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score(Baseline up to 5 years and 7 months)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score(Baseline up to 5 years and 7 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score(Up to 5 years and 7 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score(Up to 5 years and 7 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score(Up to 5 years and 7 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score(Up to 5 years and 7 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score(Up to 5 years and 7 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score(Up to 5 years and 7 months)
- Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)(Up to 5 years and 7 months)
- Serum Concentrations for JNJ-79635322(Up to 5 years and 7 months)
- Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322(Up to 5 years and 7 months)
- Very Good Partial Response (VGPR) or Better(Up to 5 years and 4 months)
- Complete Response (CR) or Better(Up to 5 years and 4 months)
- Duration of Response (DoR)(Up to 5 years and 4 months)
- Minimal Residual Disease (MRD)-negative CR(Up to 5 years and 4 months)
- MRD-negative CR at 9 months(9 months)
- Sustained MRD-negative CR(Up to 5 years and 4 months)
- Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)(Up to 5 years and 4 months)
- Overall Survival (OS)(Up to 5 years and 4 months)
- Time To Next Line of Therapy (TTNT)(Up to 5 years and 4 months)
- Number of Participants with Abnormalities in Clinical Laboratories Results(Up to 5 years and 4 months)
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score(Baseline up to 5 years and 4 months)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score(Baseline up to 5 years and 4 months)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score(Baseline up to 5 years and 4 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score(Up to 5 years and 4 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score(Up to 5 years and 4 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score(Up to 5 years and 4 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score(Up to 5 years and 4 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score(Up to 5 years and 4 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score(Up to 5 years and 4 months)
- Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)(Up to 5 years and 4 months)
- Serum Concentrations for JNJ-79635322(Up to 5 years and 4 months)
- Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322(Up to 5 years and 4 months)
- Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322(Up to 5 years and 4 months)
- Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity(Up to 5 years and 4 months)
研究者
研究点 (144)
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