EUCTR2015-001564-19-HU进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 starting study treatment
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 111
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 137
排除标准
- •- Primary refractory myeloma
- •- Refractory to bortezomib i.e. patients who progressed while receiving salvage
- •therapy with BTZ, or patients who progressed within 60 days of their most recent BTZ containing treatment.
- •- Concomitant anti-cancer therapy (other than BTZ/Dex and bisphosphonates)
- •- Prior treatment with DAC inhibitors
- •- Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 month prior to screening)
- •- 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 exclusion criteria may apply.
研究者
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