NCT07732712尚未招募2 期
Isa-VRdlite for of Frail and/or Much Older Patients With High Risk Newly Diagnosed Multiple Myeloma Base on Circulating Plasma Cells
The Affiliated People's Hospital of Ningbo University0 个研究点目标入组 15 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Overall response rate
研究概览
简要总结
To evaluate the overall response rate, safety, and the 12-cycle clearance rate of circulating plasma cells (CPCs) in patients with newly diagnosed transplant-ineligible multiple myeloma stratified as high-risk based on circulating plasma cell assessment treated with isatuximab combined with reduced-dose VRD regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Aged ≥ 18 years with newly diagnosed symptomatic multiple myeloma who have not received any prior anti-myeloma therapy.
- •Confirmed positive circulating abnormal plasma cells (CPCs) in peripheral blood via flow cytometry (CPCs ≥ 0.07%).
- •Deemed ineligible for autologous hematopoietic stem cell transplantation due to advanced age, poor physical performance, or underlying comorbidities precluding transplant tolerance.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Estimated life expectancy of at least 6 months.
- •Adequate baseline function of major vital organs to tolerate treatment; no absolute contraindications on complete blood count, liver and renal function, cardiac enzymes or coagulation profile.
- •Voluntarily participate in this study, provide written informed consent, and be available for regular follow-up visits.
排除标准
- •Diagnosis of primary plasma cell leukemia, solitary plasmacytoma, smoldering multiple myeloma or secondary multiple myeloma.
- •Prior exposure to any anti-myeloma agents, radiotherapy, or stem cell transplantation.
- •Concurrent other malignant tumors (except for in situ carcinoma cured for more than 5 years).
- •Severe active infection, active autoimmune disease, or severe cardiovascular and cerebrovascular diseases (NYHA class III-IV heart failure, recent myocardial infarction or cerebral infarction).
- •Known hypersensitivity to isatuximab, bortezomib, lenalidomide, dexamethasone, or any excipients of the study drugs.
- •Pregnant or breastfeeding females.
- •Unwilling or unable to complete follow-up, or patients with incomplete clinical data.
研究组 & 干预措施
Isa-VRdlite for high risk fail MM patinets base on CPSc
Experimental
Isa-VRdlite for high risk fail MM patinets base on CPSc
干预措施: Isatuximab (Drug)
结局指标
主要结局
Overall response rate
时间窗: 12months
defined as the proportion of patients achieving stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] or partial response \[PR\]
12-cycle clearance rate of circulating plasma cells (CPCs).
时间窗: 12months
12-cycle clearance rate of circulating plasma cells (CPCs).
次要结局
未报告次要终点
研究者
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