Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 43
- 主要终点
- Participant Characteristics and Treatment Patterns: Duration of Treatment
研究概览
简要总结
The purpose of this study is to evaluate the real-world characteristics and outcomes of participants with smoldering multiple myeloma (SMM) overall and by high-risk and non-high-risk SMM according to (AQUILA study criteria [NCT03301220], Mayo 20-2-20 and international myeloma working group (IMWG) 2020 risk classification models), and to evaluate the risk of progressing of SMM to multiple myeloma (MM) and outcomes in participants after progressing to MM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 documented diagnosis of smoldering multiple myeloma (SMM). SMM is defined as: (a) Clonal bone marrow plasma cells (BMPCs) greater than or equal to (>=) 10 percent (%) and/or serum M-protein >= 3 grams per deciliter (g/dL) and/or urine M-protein >= 500 milligram per 24 hours (mg/24hrs). (b) Absence of SLiM-CRAB criteria: >= 60 % clonal BMPCs, involved/uninvolved free light chain (FLC) ratio >= 100 and involved FLC >= 10 and magnetic resonance imaging (MRI) lesions; calcium elevation, renal insufficiency, anemia, and bone lesions (AB) criteria
- •Informed consent obtained prior to retrospective data collection in accordance with local requirements, either an informed consent form (ICF) indicating that the participants signed a consent for data collection for this research and agrees to have their data collected and analyzed, with source data verification (SDV), or the country does accept the ICF waiver for such type of studies
- •Data recorded in participants' medical charts from date of SMM diagnosis and at least 2 years after should be available in the participant's medical chart at the participating site. However, participants who died within the 2 years from SMM diagnosis are eligible
排除标准
- •Therapy for multiple myeloma (MM) initiated within 90 days of SMM diagnosis
- •Date of SMM diagnosis is missing
- •Participants who have participated/are participating in any SMM interventional (either active treatment or control arm) study are not eligible. Participation in observational studies is allowed. Participants who have participated/are participating in any MM study after evolution to MM are eligible
研究组 & 干预措施
Participants with Smoldering Multiple Myeloma (SMM)
Participants diagnosed with SMM between 01 January 2016 and 31 December 2021 will be enrolled in this study. Only data available outside of clinical studies from participant medical records will be collected. The data collected per participant in this study is defined as data available in medical charts from date of SMM diagnosis until 31 December 2023, death or lost to follow-up, whichever comes first.
结局指标
主要结局
Participant Characteristics and Treatment Patterns: Duration of Treatment
时间窗: Data collection up to 1 year and 2 months
Duration of treatment as defined from the date of first dose of SMM treatment until the last dose of SMM treatment by treatment type will be reported.
Participant Characteristics and Treatment Patterns: Time to Best Response
时间窗: Data collection up to 1 year and 2 months
Time to best response is defined as the time interval from the date of first dose of SMM treatment until recorded best response, by treatment type. Time to best response for SMM treatments will not be collected for countries which do not allow it.
Progression-free Survival
时间窗: Data collection up to 1 year and 2 months
Progression-free survival defined from the date of SMM diagnosis until date of MM diagnosis or death of any cause, whichever occurs first.
Rates of Progression From SMM to MM for High and Non-high-risk Participants
时间窗: Data collection up to 1 year and 2 months
Rate of progression from SMM to MM for high and non-high-risk participants will be evaluated as per SliM and/or CRAB criteria.
Participant Characteristics and Treatment Patterns: Number of Participants With Type of Treatment
时间窗: Data collection up to 1 year and 2 months
Number of participants with type of treatment (example, autologous stem cell transplant \[ASCT\], chimeric antigen receptor \[CAR-T\], proteasome inhibitor \[PI\], and immunomodulatory drug \[iMID\]) will be reported in participants with smoldering multiple myeloma (SMM) overall and by high-risk and non-high-risk classifications.
Participant Characteristics and Treatment Patterns: Overall Survival in Participants With SMM Overall and for High-risk and Non-high-risk Participants
时间窗: Data collection up to 1 year and 2 months
Overall survival is defined as the time interval from the date of SMM diagnosis until the date of last observation (that is, date of end of study for each participant) or death, whichever comes first.
Observation Patterns for High-risk and Non-high-risk SMM Participants and Overall
时间窗: Data collection up to 1 year and 2 months
Observational patterns (example, frequency of visits and hospitalizations) will be reported for high-risk and non-high-risk SMM participants and overall.
Time to Progression to Multiple Myeloma (MM) in Participants With High-risk SMM
时间窗: Data collection up to 1 year and 2 months
Time to progression to multiple myeloma (MM) is defined as the the time from the date of SMM diagnosis to the date of MM diagnosis, as defined by 60 percent plasma cells, light chains, and MRI lesions (SLiM) and/or calcium elevation, renal insufficiency, anemia, and bone lesions (CRAB) criteria.
Risk Factors of Progression From SMM to MM
时间窗: Data collection up to 1 year and 2 months
Potential risk factors/predictors for progression from SMM diagnosis to MM will be investigated, for high-risk participants and non-high-risk participants according to AQUILA study criteria (NCT03301220), Mayo 20-2-20 and international myeloma working group (IMWG) 2020 risk stratification models, example age at SMM diagnosis and eastern cooperative oncology group (ECOG) at SMM diagnosis.
Number of Participants With Myeloma-related Organ Damage Who Progress From SMM to MM
时间窗: Data collection up to 1 year and 2 months
Number of participants with outcomes of myeloma-related organ damage who progress from SMM to MM will be summarized overall and by high-risk and non-high-risk participants.
次要结局
- Number of Participants With Adverse Drug Reactions (ADRs)(Data collection up to 1 year and 2 months)
- Time to Best Response to MM Treatment(Data collection up to 1 year and 2 months)
- Number of Participants with Type of MM Treatment(Data collection up to 1 year and 2 months)
- Duration of MM Treatment(Data collection up to 1 year and 2 months)
- Therapies Received(Data collection up to 1 year and 2 months)
- Survival Status at End of Study(Data collection up to 1 year and 2 months)
- Number of Participants With Abnormalities in Clinical Laboratory Tests(Data collection up to 1 year and 2 months)
- Participant Characteristics With High-risk and Non-high-risk SMM(Data collection up to 1 year and 2 months)
- Best Response for the First-Line Treatment for MM(Data collection up to 1 year and 2 months)
- Overall Survival for Participants Whose SMM Evolved to MM(Data collection up to 1 year and 2 months)
- Disease Progression Related Deaths(Data collection up to 1 year and 2 months)
- Percentage of Participants With High-risk and Non-high-risk SMM(Baseline)