NCT07789522尚未招募2 期
A Clinical Study Evaluating the Safety and Efficacy of Elranatamab in Combination With Isatuximab, Bortezomib, and Lenalidomide in Patients With Ultra-High-Risk Multiple Myeloma.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Minimal residual disease (MRD) negativity rate
研究概览
简要总结
This is a prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject voluntarily signs the informed consent form (ICF).
- •Aged 18-70 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria:
- •Serum M-protein ≥1.0 g/dL
- •Urine M-protein ≥200 mg/24 hours
- •Serum involved free light chain ≥10 mg/dL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria:
- •（1）del(17p) with a clonal fraction >20% and/or a TP53 mutation （2）An IGH translocation [t(4;14), t(14;16), or t(14;20)] combined with 1q+ or del(1p32) （3）del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion （5）β2-microglobulin ≥5.5 mg/L with a normal serum creatinine level
排除标准
- •Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis.
- •Peripheral neuropathy of Grade >1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization.
- •Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients.
- •Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment.
- •Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.
结局指标
主要结局
Minimal residual disease (MRD) negativity rate
时间窗: 9 months
次要结局
- Sustained MRD negativity rate(Up to 2 year)
- Overall response rate (ORR)(Up to 2 year)
- Adverse events and serious adverse events(Up to 2 year)
- Complete response rate (CR)(Up to 2 year)
- Progression-free survival (PFS)(Up to 2 year)
- Duration of response (DoR)(Up to 2 year)
研究者
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