Retrospective Observational Study to Evaluate the Effectiveness and Safety of Belantamab Mafodotin-based Combinations (Belantamab Mafodotin, Bortezomib, Dexamethasone [BVd] or Belantamab Mafodotin, Pomalidomide, Dexamethasone [BPd]) Used as Compassionate Use in Patients With Multiple Myeloma in First or Second Relapse
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
The goal of this retrospective observational study is to characterize multiple myeloma (MM) patients (by collecting demographics, disease characteristics and treatment history data) treated in first or second relapse with belantamab mafodotin combinations under compassionate use conditions.
详细描述
This retrospective observational study will collect data from MM patients at first or second relapse to evaluate the response rates under belantamab mafodotin-based therapeutic schedules as salvage therapy.
Data from participants either treated with belantamab mafodotin+bortezomib+dexamethasone [BVd] or belantamab mafodotin+pomalidomide+dexamethasone [BPd] schedules will be evaluated. Data collection will include the following data:
- Sociodemographics (demographic data, disease status and clinical chracteristics).
- Medical history (MM diagnosis, disease characteristics and history of prior treatment with anti-MM therapies).
- Treatment with BVd or BPd (overall response rate, duration of response, progression-free survival at diagnosis, progression-free survival at relapse, duration of the treatment, overall survival, side effects, infections and concomitant treatments during the treatment with belantamab-based schedules).
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
- •Confirmed diagnosis of relapsed/refractory MM.
- •Having received at least one dose of a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions as treatment for a first or second relapse.
- •Patients ≥18 years of age at the start of treatment with the belantamab mafodotin combination (BVd or BPd) under compassionate use conditions.
排除标准
- •Any patient who has received a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions in fourth line of treatment or later will be excluded from the study.
研究组 & 干预措施
Belantamab mafodotin+Bortezomib+dexamethasone (BVd)
Participants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse.
干预措施: Belantamab mafodotin (Drug)
Belantamab mafodotin+Pomalidomide-dexamethason (BPd)
Participants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse.
干预措施: Dexamethasone (Drug)
Belantamab mafodotin+Pomalidomide-dexamethason (BPd)
Participants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse.
干预措施: Pomalidomide (Drug)
Belantamab mafodotin+Bortezomib+dexamethasone (BVd)
Participants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse.
干预措施: Bortezomib (Drug)
Belantamab mafodotin+Bortezomib+dexamethasone (BVd)
Participants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse.
干预措施: Dexamethasone (Drug)
Belantamab mafodotin+Pomalidomide-dexamethason (BPd)
Participants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse.
干预措施: Belantamab mafodotin (Drug)