NCT07266441招募中2 期
A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) 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
- 2 期
- 状态
- 招募中
- 入组人数
- 157
- 试验地点
- 93
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 monoclonal antibody (mAb)
- •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 the IMWG criteria
- •Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent
- •Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 to 2 at screening and immediately before the start of study treatment administration
排除标准
- •Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322
- •Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase
- •Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
- •Participant has leptomeningeal disease
- •Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment
研究组 & 干预措施
JNJ-79635322
Experimental
Participants will receive JNJ-79635322 as an injection under the skin.
干预措施: JNJ-79635322 (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 2 years and 9 months
次要结局
- Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity(Up to 2 years and 9 months)
- Very Good Partial Response (VGPR) or Better Rate(Up to 2 years and 9 months)
- Complete Response (CR) or Better Rate(Up to 2 years and 9 months)
- Duration of Response (DoR)(Up to 2 years and 9 months)
- Progression-Free Survival (PFS)(Up to 2 years and 9 months)
- Overall Survival (OS)(Up to 2 years and 9 months)
- Time To Next Line of Therapy (TTNT)(Up to 2 years and 9 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) Scale Score(From Baseline up to 2 years and 9 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) Scale Score(From Baseline up to 2 years and 9 months)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Score(From Baseline up to 2 years and 9 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q(Up to 2 years and 9 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30(Up to 2 years and 9 months)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L(Up to 2 years and 9 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q(Up to 2 years and 9 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30(Up to 2 years and 9 months)
- Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L(Up to 2 years and 9 months)
- Serum Concentrations for JNJ-79635322(Up to 2 years and 9 months)
- Number of Participants With Anti JNJ-79635322 Antibodies(Up to 2 years and 9 months)
- Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)(Up to 2 years and 9 months)
研究者
研究点 (93)
Loading locations...
相似试验
招募中
2 期
An Open Label Study of JNJ-68284528, Directed Against BCMA in Subjects with Multiple MyelomaMultiple Myeloma2023-506587-13-00Janssen - Cilag International56
招募中
2 期
Efficacy and Safety of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative ColitisUlcerative Colitis2023-504673-20-00Janssen - Cilag International102
招募中
3 期
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple MyelomaMultiple MyelomaNCT07258511Janssen Research & Development, LLC400
招募中
2 期
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80
招募中
1 期
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and ApixabanNCT07265466Onconic Therapeutics Inc.96