Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Favorable Response
研究概览
简要总结
Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.
详细描述
The most current treatment of multiple myeloma is based on a combination of drugs, including immunomodulators, proteasome inhibitors, etc. The VTD (bortezomib, thalidomide, and dexamethasone) and TD (thalidomide and dexamethasone) regimens are commonly used as a first-line treatment due to limited resources. The study aimed to compare the proportion of favorable responses, survival, and time to the next treatment between two different treatment approaches. The investigators designed a retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical records of patients who were considered eligible for transplant due to their functional status and who were given some treatment strategy comprising a combination of drugs.
排除标准
- •Incomplete clinical records
- •Clinical records of patients who abandoned treatment or could not continue with the treatment due to economic or distance issues
- •Clinical records of patients who presented severe sepsis before the beginning of either treatment
研究组 & 干预措施
Control Group
Thalidomide 100mg-200mg PO daily alone or in combination with dexamethasone 40mg PO every 24 hours on days 1-4, 8-11 of each cycle.
干预措施: Bortezomib (Drug)
Bortezomib Group
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (VTD).
干预措施: Bortezomib (Drug)
结局指标
主要结局
Favorable Response
时间窗: Post-induction (6 months)
Criteria established with the International Multiple Myeloma Working Group
Time to next treatment
时间窗: Post-induction (2 years)
Need for a secondline treatment after induction
次要结局
- Overall survival(3000 days)
研究者
Christian Omar Ramos-Peñafiel, MD, PhD
Principal investigator
Hospital General de Mexico