NCT07600151尚未招募1 期
A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
研究概览
简要总结
This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- •Participants must have High-risk myeloma according to IMS/IMWG CGS
- •Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
- •Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
- •Participants must have clinical laboratory values within a prespecified range.
排除标准
- •Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
- •known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
- •Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
- •known central nervous system involvement by MM.
研究者
研究点 (1)
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