JPRN-jRCT2071220010暂停1 期
[M20-917] A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab with or without Dexamethasone and in Combination with Anti-Myeloma Regimens for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
Okubo Sumiko0 个研究点目标入组 163 人开始时间: 2022年5月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 163
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
- •-- Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
- •-- Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
- •- Measurable disease per the protocol within 28 days prior to enrollment.
- •- Arm A - Lemzoparlimab with or without Dexamethasone
- •-- For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment of anti-myeloma treatments, as outlined in the protocol.
- •- Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
- •-- For Escalation Phase - Participant must have received at least 3 prior lines of therapy, as outlined in the protocol.
- •-- For Expansion Phase- Participant must have received at least 2 prior line of therapy, as outlined in the protocol.
- •- Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
- •-- For Escalation Phase- Participant must have received at least 3 prior lines of therapy as outlined in the protocol.
- •-- For Expansion Phase- Participant must have received at least 1 prior line of therapy.
- •- Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
- •-- For Both Escalation and Expansion Phase : Participant must:
- •--- Have received at least 3 prior lines of therapy, as outlined in the protocol.
排除标准
- •- Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
- •-- For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
- •- Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
- •-- For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
- •- Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
- •-- For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.
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