2025-521976-80-00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
- 54
- 试验地点
- 34
- 主要终点
- Overall response rate
研究概览
简要总结
To evaluate the efficacy of JNJ-79635322
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of MM as defined by the criteria below: a. MM diagnosis according to the IMWG diagnostic criteria (Rajkumar 2014). b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: i. Serum M-protein level ≥0.5 g/dL; or ii. Serum Ig FLC ≥10 mg/dL and abnormal serum IgκλFLC ratio; or iii. Urine M-protein level ≥200 mg/24h
- •Received at least 3 prior lines of antimyeloma therapy including a PI, an IMiD, and an anti-CD38 mAb.
- •Documented evidence of PD or failure to achieve a response (ie, PR or better) 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. Toxicity related to prior anticancer treatment must have resolved to Grade 1 or better (except alopecia, skin fibrosis or discoloration, dry mouth, endocrinopathy managed with replacement therapy, peripheral neuropathy, and dysgeusia, which must be Grade 2 or better)
- •Have an ECOG PS of 0 to 2 at screening and immediately before the start of study treatment administration (Oken 1982).
排除标准
- •Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 (refer to the IB)
- •Had major surgery within 2 weeks before first dose or has planned major surgery during study Treatment Phase. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
- •Participant has a prior or concurrent second malignancy (other than the disease under study) the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s) (see Section 10.5 on Allowed Recent Second or Prior Malignancies for details).
- •Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- •Participant has leptomeningeal disease
研究组 & 干预措施
JNJ-79635322, JNJ-79635322
Test
干预措施: JNJ-79635322 (Drug)
结局指标
主要结局
Overall response rate
Overall response rate
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (34)
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