LBCTR2019010183已完成2 期
A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents”
SecuraBio0 个研究点目标入组 9 人开始时间: 2020年8月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •multiple myeloma as per IMWG 2014 definition
- •requiring treatment for relapsed or relapsed/refractory disease
- •measurable disease based on central protein assessment
- •1 to 4 prior lines of therapy
- •prior IMiD exposure
- •acceptable lab values prior to randomization
排除标准
- •Exclusion Criteria:
- •primary refractory myeloma
- •refractory to bortezomib
- •concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
- •prior treatment with DAC inhibitors
- •Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization)
- •Unresolved diarrhea = CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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