A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 主要终点
- 2-year Progression-free Survival Rate
研究概览
简要总结
The purpose of this study is to assess the 2-year progression-free survival rate.
详细描述
This was a prospective, open-label, multicenter, observational study. Participants who received bortezomib, Melphalan, Prednisone(VMP) therapy for Multiple myeloma (MM) that was not eligible for autologous stem cell transplantation will be enrolled in the study. The study will consist of Screening phase; VMP therapy phase (9cycles); Follow-up phase (2 years from the day when the first cycle was started). Participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first VMP administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment). Participants receiving VMP therapy will be primarily evaluated for 2-year progression-free survival rate. Participants safety will be monitored throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation
- •Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol
- •Participants with presence of an illness that is detectable by definitions as defined in protocol
- •Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial
排除标准
- •Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone < 160mg in total)
- •Participants with severe peripheral neuropathy (Grade >= 2 by NCI CTC version 4.0)
- •Pregnant or breastfeeding mothers
- •Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial
- •Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)
研究组 & 干预措施
Bortezomib, Melphalan, Prednisone (VMP) Group
Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
干预措施: Bortezomib (Drug)
Bortezomib, Melphalan, Prednisone (VMP) Group
Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
干预措施: Melphalan (Drug)
Bortezomib, Melphalan, Prednisone (VMP) Group
Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
干预措施: Prednisone (Drug)
结局指标
主要结局
2-year Progression-free Survival Rate
时间窗: Up to 2 years
Progression-free survival rate: the length of time from the day when Bortezomib was first administered to disease progression or death, whichever comes first, in 2 years.
次要结局
- Overall Response Rate(up to 2 years)
- Time to Next therapy(up to 2 years)
- Complete Response Rate(up to 2 years)
- Time to Response(up to 2 years)
- Time to Disease Progression(up to 2 years)