A Multi-center,Open, Longitudinal, Observational Study to Evaluate the Treatment Effectiveness and Safety of the Bortezomib-melphalan-prednisolone Regimen in Treatment-naïve Patients With Multiple Myeloma, Ineligible for Hematopoietic Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 24
- 主要终点
- PFS (progression-free survival)
研究概览
简要总结
The 3-drug therapy of Bortezomib-Melphalan-Prednisolone (VMP) is a standard therapy that is commonly used currently in South Korea as a first-line treatment for treatment-naïve patients with multiple myeloma who are ineligible for hematopoietic transplantation. Despite the fact that VMP therapy is outstanding in terms of cost-effectiveness, treatment discontinuation rates due to adverse drug reactions is high. In addition, when considering that the percentage of elderly patients aged 70 years or above in the target patient group is 20% or above, there have been attempts to devise a plan that can decrease side effects while maintaining effectiveness. For example, there have been previous reported cases of overseas applications of modified VMP therapies with reduced doses, but they have applied various combinations in terms of the total cycles, administration intervals, doses, etc. This study was planned to evaluate the overall safety and efficacy of VMP therapy by following up on the actual VMP therapies applied in domestic clinics, patient characteristics, side effect occurrences, administration discontinuation rates, survival data, etc., as well as to collect exploratory data for a more effective study of modified VMP therapies.
This study was planned to evaluate the overall safety and efficacy of VMP therapy by following up on the actual VMP therapies applied in domestic clinics, patient characteristics, side effect occurrences, administration discontinuation rates, survival data, etc., as well as to collect exploratory data for a more effective study of modified VMP therapies.
详细描述
The data produced when subjects visit the hospital for treatment are collected in case report forms. The follow-up time specified in the following refer to the data collection time. That is, a subject's visit schedule is freely determined by the investigator based on the medical condition of the subject regardless of the follow-up time specified in this protocol, but data that are determined necessary in relation to the study among the data produced during the study period may be collected in CRFs.
In regard to various tests for monitoring of treatment effects including laboratory tests, the corresponding tests are not performed separately for this clinical study, and only those items with existing test results are collected. The following data are collected in CRFs during the study period.
- Demographic information of subjects
- Information on multiple myeloma disease (diagnosis date, diagnosis criteria and related test results, disease stage [ISS and revised ISS], number of osseous lesions)
- Intercurrent diseases
- Height and body weight
- ECOG PS
- IMWG Frailty score
- Laboratory results
- Radiologic results
- Bone marrow examination results
- Supportive therapy administered for symptoms related to multiple myeloma (drug / surgery / radiotherapy)
- Detailed information of administered VMP therapy
- Maintenance therapy / VMP replacement therapy
- Clinical response
- Survival
- Adverse drug reactions related to VMP therapy
- Serious adverse events/adverse drug reactions
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who provide written consent on the informed consent form for use of personal information after listening to an explanation regarding the purpose, method, etc., of this clinical study
- •Adult males and females aged 19 years or above
- •Patients without previous experience of treatment for multiple myeloma who have been evaluated as ineligible for hematopoietic transplantation
- •Patients scheduled to receive the 3-drug combination (VMP therapy) treatment
- •Patients with expected survival period of 6 months or more
- •Patients evaluated as having performance status score (ECOG PS) ≤2 (score of 0, 1, 2)
- •Patients who have received the following tests within 6 months prior to enrollment
- •Beta2-microglobulin
- •Serum albumin
- •Serum LDH
- •Patients with confirmed del (17), t (4;14), t (14;16) by hybridization FISH test
排除标准
- •Patients who have been newly diagnosed with other primary cancers within the last 5 years that can affect the treatment or prognosis of multiple myeloma
- •Pregnant women and breast-feeding women
- •Patients who are currently participating in other clinical studies (drug or medical device clinical studies) or planning to participate in other clinical studies during the study participation period
- •Patients who are determined ineligible to participate in the study by other judgments of the investigator
结局指标
主要结局
PFS (progression-free survival)
时间窗: 18 Month after VMP therapy administration
the survival rate curve of PFS and the median, as well as the 95% confidence interval for this are presented. An event is 'confirmation of progressive disease (PD)' or 'death,' and others are processed as censored at the later time point between the final follow-up time point and the time point of final clinical response evaluation.
次要结局
- CR (Complete Response)(18 Month after VMP therapy administration)
- Prognosis prediction factors(18 Month after VMP therapy administration)
- Time to Progression (TTP)(18 Month after VMP therapy administration)
- Time to Next Treatment (TTNT)(18 Month after VMP therapy administration)
- Time to Response (TTR)(18 Month after VMP therapy administration)
- ORR (Overall Response Rate)(18 Month after VMP therapy administration)
- OS (Overall Survival)(18 Month after VMP therapy administration)
- Percentage of IMWG frailty scores at Cycle 5 and Cycle 9(18 Month after VMP therapy administration)