Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Portugal: an Observational, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 8
- 主要终点
- Number of MM Participants Categorized by Clinical Variables at Last R/R Episode
研究概览
简要总结
The main aim of this study is to see how people with MM respond to previous or current treatment.
Participants will be treated according to their clinic's standard practice. Each participant will fill out a study questionnaire during a routine doctor visit. Information collected from past medical records will also be used.
详细描述
This is a non- interventional, retrospective epidemiological study of participants with MM. The study will characterize MM participants with symptomatic relapse and/or refractory (R/R) disease.
The study will enroll approximately 151 participants. The study will have a retrospective data collection referring to previous 5 years from participants' records and medical charts regarding diagnosis, disease activity, treatment patterns, and healthcare resources while quality of life (QoL) will be obtained from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC QLQ-MY20 questionnaires. All participants will be enrolled in one observational group.
This multi-center trial will be conducted in Portugal. The overall time to participate in this study is limited to completion of a questionnaire at the time of joining the study.
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
- •At least one previous treatment line.
- •Symptomatic R/R disease in the previous 6 months to study enrolment.
- •Receiving treatment with an accurate and thorough data fulfilled in their participant's medical records available at the study site.
- •On regular follow-up for relapse and/or refractory disease during the recruitment period at the study site.
- •Capable of understanding and completing both QoL questionnaires (EORTC QLQ-C30 and EORTC QLQ-MY20).
排除标准
- •Diagnosed with MM more than 5 years previous to inclusion in this study.
- •Diagnosed with any malignancy other than MM or its complications within the past 5 years.
- •Currently participating in a clinical trial for his MM or having participated in a clinical trial within 5 years before inclusion.
- •Diagnosed with any hematological disease other than MM or its complications.
结局指标
主要结局
Number of MM Participants Categorized by Clinical Variables at Last R/R 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, lactate dehydrogenase levels, paraprotein levels, free light chain levels); concomitant diseases (diabetes, neuropathy, chronic obstructive pulmonary disease, cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders); cytogenetic abnormalities at diagnosis; risk according to cytogenetic profile at relapse; treatment started after latest symptomatic relapse and/or refractory episode.
Number of MM Participants Categorized by Sociodemographic Variables
时间窗: Day 1
The sociodemographic variables will include age (in years), sex (male or female), body mass index (BMI), area of residence (rural or urban), educational level (illiterate, no studies (can only read/write), primary studies, secondary studies, or university studies), cohabitation (lives alone, lives with the family, lives alone with help from a caregiver, daily, 2-3 times/week, permanent or night-time), degree of dependence (independent, dependent grade I- requires help to perform instrumental activities of daily living (IADL) at least once a day, dependent grade II- needs help to perform IADLs 2 or 3 times a day or dependent grade III- needs help to perform IADLs several times a day),working situation (unemployed, in active employment, temporarily/permanently disabled, retired, student, other, need for financial assistance (yes/no), physical activity (high, moderate/low, inactive), smoking habit (yes/no), alcohol use (yes/no).
Number of MM Participants Categorized by Clinical Variables on Diagnosis and During Previous Relapses
时间窗: Day 1
Clinical variables will include age (at diagnosis); MM type; international staging system (ISS) disease stage; Revised-ISS (R-ISS) disease stage; SliMCRAB signs at time of diagnosis: plasma cell bone marrow infiltration greater than or equal to (\>=) 60 percent (%), serum free light chain (FLC) ratio \>=100, \>1 focal lesion visible on magnetic resonance imaging (MRI) with 5 millimeter (mm) or greater, increased blood calcium, renal failure, anemia, bone lesions: one or more osteolytic lesion on standard radiograph, computed tomography (CT) or Positron emission tomography-CT (PET-CT); cytogenetic abnormalities at time of diagnosis (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 at diagnosis (mSMART v2 and mSMART v3); previous relapses (before the latest); stem cell transplant (yes/no); eastern cooperative oncology group (ECOG: 0-4) on diagnosis.
Number of Participants Categorized by Current Treatment
时间窗: Day 1
Type of treatment will include therapeutic group.
次要结局
- Number of Participants Categorized by Relevant Variables that are not Currently Collected in Clinical Record and Could Influence in the Disease Management at Relapse(Day 1)
- Number of Participants Categorized by Sociodemographic Characteristics at the Latest Symptomatic R/R Episode per Type of Treatment(Day 1)
- Number of MM Participants Categorized by Clinical Variables at Latest Symptomatic R/R Episode per Type of MM(Day 1)