NCT00532675已完成1 期
A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
研究概览
简要总结
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PAN 10 mg
Experimental
Panobinostat 10 mg
干预措施: LBH589 (Drug)
PAN 10 mg
Experimental
Panobinostat 10 mg
干预措施: Lenalidomide (Combination Product)
PAN 5 mg
Experimental
Panobinostat 5 mg
干预措施: LBH589 (Drug)
PAN 5 mg
Experimental
Panobinostat 5 mg
干预措施: Lenalidomide (Combination Product)
PAN 20 mg
Experimental
Panobinostat 20 mg
干预措施: LBH589 (Drug)
PAN 20 mg
Experimental
Panobinostat 20 mg
干预措施: Lenalidomide (Combination Product)
PAN 25 mg
Experimental
Panobinostat 25 mg
干预措施: LBH589 (Drug)
PAN 25 mg
Experimental
Panobinostat 25 mg
干预措施: Lenalidomide (Combination Product)
结局指标
主要结局
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
时间窗: 24 weeks
次要结局
- Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment(Da1 to Day 3 (week 1 of first cycle))
研究者
研究点 (4)
Loading locations...
相似试验
终止
2 期
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell LymphomaDiffuse Large B-cell LymphomaNCT00474188Celgene Corporation26
已完成
2 期
A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple MyelomaHematologic CancerNCT00742560AbbVie (prior sponsor, Abbott)101
已完成
2 期
Study of Lenalidomide and Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT01593410Celgene194
招募中
2 期
VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple MyelomaMyelomaNewly DiagnosedHigh RiskNCT03641456Sun Yat-sen University50
已完成
早期 1 期
Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple MyelomaMyelomaNCT01861340Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins20