Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 30
- 主要终点
- Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
研究概览
简要总结
The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
详细描述
Adult participants with a diagnosis of MM who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study.
The study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected.
The study will enroll approximately 350 patients.
This multi-center trial will be conducted in a total of 30 public sites in Spain. The overall time to collect data will be approximately 1 year from June 2017 to May 2018.
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
- •Have a diagnosis of MM and has received at least one previous treatment line.
- •Have experienced symptomatic relapse and/or refractory disease in the 6 months before the study.
- •Has continued in follow-up at the time of the study visit.
- •Is currently treated in the site who have clinical records available.
- •Is capable of understanding and completing the questions in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and EORTC Multiple Myeloma Module (QLQ-MY20) questionnaires.
排除标准
- •Participants who do not agree to participate in the study or who do not give written informed consent.
结局指标
主要结局
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
时间窗: Day 1
Sociodemographic variables included age(in years), sex(male or female), body mass index(BMI), residence(rural or urban), educational level(illiterate,no studies(can only read/write),primary studies,secondary studies,higher studies), work status(unemployed,active employment,temporarily/ permanently disabled, retired, other), cohabitation(lives-alone,with relatives,alone with help from a caregiver), need for financial assistance (yes/no), degree of dependence(independent,dependent:grade I-requires help to perform activities of daily living \[ADL\] at least once a day,grade II-needs help to perform ADLs 2 or 3 times a day or grade III-needs help to perform ADLs several times a day), healthy habits (high\[jogging;climbing;cycling;swimming;sports;intensive work;moving \>20 kg loads\], moderate\[walking;dancing;domestic chores;sports with children,walking house pets;general construction work;moving \<20 kg loads\] physical activity or inactive, smoking habit (yes/no), alcohol use (yes/no).
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
时间窗: Day 1
Clinical variables at Diagnosis included age,MM type(heavy/light chain/Bence-Jones protein), international staging system(ISS),disease stage(I:low risk,β2-Microglobulin\<3.5mg/L and albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-Microglobulin≥5.5mg/L),calcium,renal insufficiency,anemia or bone lesions(CRAB) signs(serum calcium\>0.25mmol/L upper limit of normal,renal failure-creatinine clearance\<40mL/min/serum creatinine\>117μmol/L, anemia:reduction of hemoglobin(Hb)\>2g/dL below lower limit of normal or Hb\<10g/dL,bone lesions 1/more osteolytic lesion,cytogenetic abnormalities(t\[4;14\],t\[11;14\],t\[14;16\],t\[14;20\],t\[6;14\],trisomies,d\[17p\],g\[1q\]/others), risk according to cytogenetic profile(standard:trisomies,t\[11;14\];t\[6;14\],intermediate:t\[4;14\],g\[1q\], high:d\[17p\],t\[14;16\],t\[14;20\],other), eastern cooperative oncology group(ECOG) status (0:fully active,1:restricted physical activity,2:ambulatory,unable to carry out any work,3:capable of limited selfcare,4:completely disabled,5:dead).
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
时间窗: Day 1
Clinical variables include date of latest symptomatic relapse and/or refractory episode, ISS disease stage, CRAB signs, other clinical variables (plasmacytomas: medullary or extramedullary, diffuse osteopenia, fractures, neurological symptoms, infections, concomitant diseases like diabetes, neuropathy, chronic obstructive pulmonary disease (COPD), cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders, cytogenetic abnormalities, risk according to cytogenetic profile at relapse(standard:trisomies,t\[11;14\];t\[6;14\],intermediate:t\[4;14\],g\[1q\], high:d\[17p\],t\[14;16\],t\[14;20\],other), treatment started after latest symptomatic relapse and/or refractory episode.
次要结局
- Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse(Day 1)
- Percentage of Participants With Health Care Resource Utilization (HU)(Day 1)
- HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)(Day 1)
- Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode(Day 1)
- Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30(Day 1)
- HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score(Day 1)