Analysis of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Receiving Pomalidomide-Containing and Non-Pomalidomide-Containing Regimens in the Real World: A OneOncology United States Database Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens
研究概览
简要总结
This retrospective observational study will use data from the OneOncology United States database to evaluate clinical outcomes in adults with relapsed/refractory multiple myeloma who received pomalidomide-containing or non-pomalidomide-containing treatment as second-line or third-line therapy after prior exposure to lenalidomide and a proteasome inhibitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Have a diagnosis of multiple myeloma (ICD-9: 203.00; ICD-10: C90.0x, C90)
- •Are ≥18 years of age at the index date
- •Have received a lenalidomide-containing regimen and received a proteasome inhibitor; exposures do not need to occur within the same line of therapy
- •Have received ≥1 subsequent lines of therapy after lenalidomide and proteasome inhibitor exposure
- •Have received one of the following treatment regimens as the subsequent line (index line) after lenalidomide and proteasome inhibitor exposure:
- •Pomalidomide-containing regimens:
- •Daratumumab, pomalidomide, and dexamethasone (DPd)
- •Carfilzomib, pomalidomide, and dexamethasone (KPd)
- •Non-pomalidomide-containing regimens:
- •Daratumumab, lenalidomide, and dexamethasone (DRd; lenalidomide-refractory participants only)
- •Daratumumab, bortezomib, and dexamethasone (DVd)
- •Daratumumab, carfilzomib, and dexamethasone (DKd)
排除标准
- •Have <6 months of follow-up from the index date; participants who died will be included even with <6 months follow-up, but participants who died within 1 month after the index date will be excluded
- •Have <6 months pre-index enrollment
- •Have other primary cancer diagnoses within 1 year pre-index
- •Excluded ICD-10 diagnosis codes: C00.xx-C76.xx, C7A, C80.xx-C88.xx, C91.xx-C96.xx, D00.xx-D09.xx, D37.xx-D47.1x, D47.3x-D49.xx
- •Excluded ICD-9 diagnosis codes: 149.x through 239.x
- •ICD codes 209.4, 209.5, 209.6, 209.7, D47.Z1, D47.Z2, and D3A will not be excluded
- •Received chimeric antigen receptor T-cell therapy or bispecific antibody therapy before index date or as the index line
- •Have ever enrolled in a clinical trial
结局指标
主要结局
Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens
时间窗: Up to 6 years
Overall Survival (OS) among participants who initiated pomalidomide-containing index regimens
时间窗: Up to 6 years
Overall Response Rate (ORR) among participants who initiated pomalidomide-containing index regimens
时间窗: Up to 6 years
Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens
时间窗: Up to 6 years
TTNT is defined as the time from initiation of the pomalidomide-containing index regimen to initiation of the next subsequent line of therapy.
次要结局
未报告次要终点