An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 54
- 试验地点
- 46
- 主要终点
- Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
研究概览
简要总结
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
详细描述
An Open-label, Phase 2 Study Treating Subjects with First or Second Relapse of Multiple Myeloma with Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
This trial is designed to estimate the efficacy of a carfilzomib-based triplet in first or second relapse of multiple myeloma for subjects refractory to lenalidomide. The study is an open-label, phase 2 trial. Subjects may receive treatment until progression.
Myeloma disease status will be monitored locally for response and progression per International Myeloma Working Group (IMWG) criteria (Kumar et al, 2016) every 28 ± 7 days from cycle 1 day 1 until confirmed progressive disease (PD), death, lost to follow-up, or withdrawal of full consent (whichever occurs first), regardless of cycle duration, dose delays or treatment discontinuation. Subjects with a suspected complete response (CR) or better will have a bone marrow for minimal residual disease (MRD) assessment at 12 and 24 months (± 4 weeks) from start of treatment (unless a MRD assessment was performed within 4 months before planned assessment).
Subjects who end study drug(s) without confirmed PD are required to complete disease response assessments and report new anti-myeloma treatment every 28 ± 7 days until first subsequent anti-myeloma treatment, death, lost to follow-up, withdrawal of full consent, confirmed PD, or end of study, whichever occurs first. Subjects who discontinue treatment and either start new anti-myeloma treatment or have PD will enter long-term follow-up every 12 weeks until death or end of study.
Approximately one-third of subjects enrolled in the study will be in first relapse and two-thirds in second relapse.
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 99 Years（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
Carfilzomib combined with pomalidomide and dexamethasone
Carfilzomib, pomalidomide, and dexamethasone (KPd)
干预措施: Carfilzomib (Drug)
Carfilzomib combined with pomalidomide and dexamethasone
Carfilzomib, pomalidomide, and dexamethasone (KPd)
干预措施: Dexamethasone (Drug)
Carfilzomib combined with pomalidomide and dexamethasone
Carfilzomib, pomalidomide, and dexamethasone (KPd)
干预措施: Pomalidomide (Drug)
结局指标
主要结局
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
时间窗: From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks
Overall response was defined as the best overall confirmed response of: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Assessment was by IRC per International Myeloma Working Group Uniform Response Criteria (IMWG-URC). The 90% confidence intervals were estimated using the Clopper-Pearson method (1994).
次要结局
- Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC(Day 1 cycle 1 to month 12 (8 to 13 month window))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occured earlier; Median (min, max) was 8.5 (1.0, 46.6) months)
- Number of Participants Achieving MRD[-] Response(From day 1 cycle 1 until the end of study (EOS); the mean duration of KPd treatment as of the EOS was 55.3 weeks)
- Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC(Day 1 cycle 1 to month 12 (8 to 13 month window))
- Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC(Day 1 cycle 1 to month 26 (19 to 26 month window))
- Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC(From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks)
- Time to Response as Assessed by the IRC(From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks)
- Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC(From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks)
- Kaplan-Meier Estimate of Overall Survival (OS)(From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks.)
- Number of Participants With Best Overall Confirmed Response of CR or Better as Assessed by the IRC(From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks)