A Phase II, Multi-center, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient had a previous diagnosis of multiple myeloma
- •Patient required retreatment for multiple myeloma
- •Patient had measurable M component in serum or urine at study screening
排除标准
- •Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
- •Patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
- •Patient received prior treatment with DAC inhibitors including panobinostat
- •Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG
研究组 & 干预措施
LBH589 + bortezomib + dexamethasone
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
干预措施: bortezomib (Drug)
LBH589 + bortezomib + dexamethasone
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
干预措施: LBH589 (panobinostat) (Drug)
LBH589 + bortezomib + dexamethasone
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
干预措施: dexamethasone (Drug)
结局指标
主要结局
Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate
时间窗: after 24 weeks (8 cycles; cycle = 21 days)
nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.
次要结局
- Overall Response Rate (ORR)(24 weeks (8 cycles; cycle = 21 days))
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose)
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose)
- Progression Free Survival (PFS)(duration of study up to approx. 4 years)
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose)
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose)
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose)
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose)
- Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F(Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose)
- Overall Survival (OS)(up to 30 days after end of study, approx. 4 years)
- Time to Response (TTR) Per Investigator(duration of study up to approx. 4 years)
- Time to Progression/Relapse (TTP) Per Investigator(duration of study up to approx. 4 years)
- Duration of Response (DOR) Per Investigator(duration of study up to approx. 4 years)
- Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156)
- Minimal Response Rate (MRR) Per Investigator(after 24 weeks (8 cycles; cycle = 21 days))