Multiple Myeloma Profile in Brazil: A Retrospective Observational Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 943
- 试验地点
- 17
- 主要终点
- Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
研究概览
简要总结
The purpose of this study is to present a descriptive analysis of demographic and clinical characteristics of the participants, as well as of the treatment patterns for multiple myeloma (MM) in Brazil.
详细描述
Participants with a diagnosis of MM will be observed in this retrospective study. Data collected for the study will include identification, demographic, baseline data on MM, additional baseline laboratory, initial treatment for MM, subsequent treatment for MM, and outcome.
The study will enroll approximately 1000 participants.
This multi-center trial will be conducted in five geographic regions of Brazil. For each participant, data collection will comprise the longest possible period of time since the diagnosis of MM (within the eligibility window of time, between January 1, 2008 and December 31, 2016) and the cut-off date for data collection (December 31, 2016), unless a participant has died or been lost to follow-up before that. The study is planned to last for approximately 24 months since its initiation (initiation defined as the initiation visit for the first site).
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
- •Provision of written informed consent, for participants who are alive and not lost to follow-up (for participants already deceased or lost follow up, informed consent should have been waived by the corresponding ethics review board [ERB]).
- •Documented diagnosis of MM by the responsible physician between January 1, 2008, and December 31,
- •Absence of any plasma-cell disorder other than MM.
- •Absence of any immunoglobulin-related disorder other than MM.
排除标准
- 未提供
结局指标
主要结局
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
时间窗: From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years]
MM clinical characteristics upon diagnosis were classified by eligibility criteria for transplantation (eligible/not eligible) and included: presence of plasma cells in the bone marrow by biopsy and aspiration, bone or extramedullary biopsy, plasma cells determined by immunohistochemistry (Yes/No/Unknown), plasma cells determined by flow cytometry (Yes/No/Unknown) hypercalcemia, renal failure, anemia, and bone lesions features (more than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size), presence of monoclonal proteins (immunoglobulin (Ig)G, IgG kappa, IgG lambda, IgA, IgA kappa, IgA lambda, kappa only, lambda only, IgD, IgE, IgM, Non-secretory and Unknown), free light chain ratio (serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L). Only categories with data are reported. Participants were counted multiple times in different categories.
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
时间窗: From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years]
Treatment patterns were collected from institutional charts \[included public institution, private institution and both (90% public and 10% private) institutions\] of participants in Brazil. The treatment patterns were collected as induction treatment, consolidation treatment, maintenance treatment performed at Baseline (at initial diagnosis) and as a induction treatment, maintenance treatment and type of treatment performed after transplantation, for second to tenth line of treatment. Only categories with data are reported. Participants were counted multiple times in different categories.
次要结局
- Overall Survival (OS)(From the date of diagnosis up to death within the period of interest (between January 1, 2008, and December 31, 2016) or up to the end of this study [up to 11.7 years])
- Duration of Treatment(From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first up to the end of this study (up to 11.7 years))