CTIS2023-503689-21-00招募中1 期
An Open-label, Randomized Phase Ib/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma - BP43437
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •??Agreement to provide protocol-specific bone marrow biopsy and aspirate samples, ??Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, ??Life expectancy of at least 12 weeks, ??Documented diagnosis of MM according to the International Myeloma Working Group (IMWG) diagnostic criteria, ??Evidence of progressive disease based on Investigator’s determination of response by IMWG criteria on or after last dosing regimen, ??Participants with r/r MM who previously received therapy, including an immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). Both anti-CD38 naïve and anti-CD38 exposed/refractory participants are allowed
排除标准
- •??Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of forimtamig, tocilizumab, or carfilzomib, or 102 days after the last dose of daratumumab, ??Plasma cell leukemia with circulating plasma cell count = 5% or >500/µL, ??Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis, ??Participants with current amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy), ??Participants with myelodysplastic syndrome, ??Participants with (extramedullary) lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare. Participants may be eligible after discussion with the Medical Monitor
研究者
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