Latin American Multiple Myeloma Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,059
- 试验地点
- 22
- 主要终点
- Demographic Characteristics of Multiple Myeloma (MM) Participants
研究概览
简要总结
The purpose of this study is to characterize the multiple myeloma (MM) population concerning demographics and clinical characteristics (for example. frailty, risk strata, manifestations of target organ damage [TOD]) in 6 countries (that is Argentina, Brazil, Mexico, Chile, Colombia and Panama); and to profile the treatment landscape of Latin American MM participants, including factors associated with health-care provider (HCP) selections of different treatment regimens. These factors can include a participant's demographic and clinical characteristics and availability of different therapy options per institution in each country.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incident diagnosis of MM between 01 January 2016 and 31 December 2020 (that is the first observed diagnosis noted in the medical charts)
- •An informed-consent form (ICF) or participation agreement must be signed before any data are collected only if a waiver is not permissible. For deceased participants who did not provide consent before death, the permission to research on their information should satisfy the local requirements (that each study site's ethics committee and each country's regulatory authority)
排除标准
- •Failed to satisfy one or more of the foregoing inclusion criteria or
- •Only with diagnosis of smouldering myeloma between 01 January 2016 and 31 December 2020 in the medical charts
结局指标
主要结局
Demographic Characteristics of Multiple Myeloma (MM) Participants
时间窗: Baseline
Demographic characteristics (such as age, gender, race, ethnicity, country of residence, and health insurance) of MM participants will be assessed at baseline.
General Health Status Based on Frailty Score
时间窗: Approximately up to 2.7 years
General health status based on Frailty Score will be reported. International Myeloma Working Group (IMWG) frailty score: Participants frailty status will be assessed on the basis of 4 components: age (less than \[\<75\], 76- 80, and greater than \[\>\]80 years correspond to frailty scores of 0, 1, and 2, respectively), the charlson comorbidity scoring system without age weighting (scores of less than or equal to \[\<=\]1 and greater than or equal to \[\>=\]2 correspond to frailty scores of 0 and 1, respectively), independence in activities of daily living (scores of \>4 and \<=4 correspond to frailty scores of 0 and 1, respectively) and instrumental activities of daily living scale (scores of \>5 and \<=5 correspond to frailty scores of 0 and 1, respectively). The sum of the 4 frailty scores equals the total frailty score. The total frailty score ranges from 0 to 5, with a total of three categories: 0 (fit), 1 (intermediate-fitness) and greater than or equal to (\>=)2 (frail).
Number of Participants with Comorbid Conditions
时间窗: Baseline
Number of participants with comorbid conditions (such as obesity, diabetes, cardiovascular disease, anemia alcohol, and tobacco use) will be assessed at baseline.
Sequence of Treatments in Participants with Multiple Myeloma (MM)
时间窗: Approximately up to 2.7 years
Treatment sequences for participants with MM within routine clinical care will be assessed.
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
时间窗: Approximately up to 2.7 years
ECOG performance status is a standard criterion for measuring how the disease impacts daily living abilities. It describes the level of functioning in terms of the ability to care for oneself, daily activity, and physical ability (walking, working, etc). ECOG performance status score ranges from Grade 0 to 5: 0= Fully active and performances without restriction, 1= Restricted in physically strenuous activity, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, 3= Capable of only limited self-care and confined to bed or chair more than 50% of waking hours, 4= Completely disabled, and 5= Dead.
Number of Participants in Each Stage of Multiple Myeloma (MM) Disease
时间窗: Approximately up to 2.7 years
Number of participants in each stage of MM disease will reported. The stage of MM disease will be determined by International Staging System (ISS). ISS categorizes MM participants into three groups (Stage I, II, or III). Stage I: beta2-microglobulin less than (\<)3.5 milligram per liter (mg/L) and albumin greater than or equal to (\>=)3.5 gram (g)/100 milliliter (mL); stage II: neither stage I nor stage III; and stage III: beta2-microglobulin \>=5.5 mg/L.
次要结局
- Overall Survival (OS)(Approximately up to 2.7 years)
- Progression-Free Survival (PFS)(Approximately up to 2.7 years)
- Percentage of Participants with Complete Response (CR)(Approximately up to 2.7 years)
- Time to Next Treatment(Approximately up to 2.7 years)
- Number of Participants who Underwent Different Types of Minimal Residual Disease (MRD) Tests(Approximately up to 2.7 years)
- Duration of Response(Approximately up to 2.7 years)
- Percentage of Participants with Stringent Complete Response (sCR)(Approximately up to 2.7 years)
- Percentage of Participants who Adopted Treatment Regimens(Approximately up to 2.7 years)
- Number of Participants with Adverse Events(Approximately up to 2.7 years)