Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 705
- 试验地点
- 114
- 主要终点
- Time to carfilzomib dose modification
研究概览
简要总结
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting.
This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.
详细描述
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting.
The Primary Objective is to describe carfilzomib utilisation in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation.
- Secondary Objectives:
- Describe the population treated with carfilzomib in terms of demographics, multiple myeloma (MM) disease characteristics, treatment history, and comorbidities.
- Describe the safety profile of carfilzomib in routine clinical practice.
- Describe response to treatment as assessed by the physician and recorded in the medical file.
- Describe healthcare resource utilisation of subjects treated with carfilzomib, in terms of unplanned hospitalisations.
- Describe the reasons for choosing carfilzomib as the MM treatment of choice.
- Describe specific concomitant therapy (bisphosphonates, thromboprophylaxis, antihypertensive treatment, anti-infective treatment) and whether these therapies were used as prophylaxis or as treatment.
- Describe a cardiovascular assessment at carfilzomib regimen initiation and at occurrence of cardiac adverse events, where available per routine care (electrocardiogram [ECG], echocardiography, left ventricular ejection fraction).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age 18 years or older at the time of carfilzomib initiation
- •At least one prior line of MM treatment has been received
- •Carfilzomib treatment has been initiated per routine practice and is currently ongoing
- •At least one administration of carfilzomib in a combination regimen (ie, not monotherapy) has been received
- •Provided written informed consent prior to abstraction of any data, in countries where written informed consent is required.
- •Subjects who previously completed treatment with carfilzomib in a clinical trial, a compassionate use program or through routine practice, are eligible to take part in the study.
- •Subjects who receive radiotherapy concurrently with carfilzomib treatment are also eligible to take part in the study.
- •Subjects who initiate carfilzomib treatment on a combination regimen, subsequently discontinue all concomitant medications but remain on carfilzomib monotherapy in later cycles, remain eligible for participation in the study.
- •Subjects who are also enrolled in other observational studies in which standard of care is not altered are eligible to take part in the study,
排除标准
- •Subjects who are enrolled in a carfilzomib clinical trial will not be eligible to additionally take part in this observational study.
- •Subjects who are receiving carfilzomib treatment within a compassionate use program will not be eligible to take part in this observational study. If a subject who has enrolled into this observational study, also enrolls in a clinical trial in which MM treatment and/or disease management is protocol-specified, the subject becomes ineligible and the subject's data will be censored from the time the subject enrolled the clinical trial.
结局指标
主要结局
Time to carfilzomib dose modification
时间窗: 18 months
At least one carfilzomib dose modification, escalation or reduction
Carfilzomib regimen
时间窗: 18 months
Treatment combination
Carfilzomib dosing frequency
时间窗: 18 months
Number of administrations per cycle
Carfilzomib dose modification
时间窗: 18 months
Modification includes change in dose level, dose interruption, and dose delays
Reason for dose modification
时间窗: 18 months
Reason for dose modification or delay
Number of cycles started
时间窗: 18 months
Number of carfilzomib treatment cycles started throughout study period
Carfilzomib duration of treatment
时间窗: 18 months
Duration of carfilzomib treatment
Starting dose of concomitant anti-myeloma agents
时间窗: 18 months
Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline
Dose modification for concomitant anti-myeloma agents
时间窗: 18 months
Modification includes change in dose level, dose interruption, and dose delays
Carfilzomib starting dose
时间窗: 18 months
Carfilzomib dose at first administration
Carfilzomib dose
时间窗: 18 months
Carfilzomib dose at subsequent administrations
Carfilzomib dosing schedule
时间窗: 18 months
Timing of carfilzomib administration within treatment cycle
Reason for frequency modification
时间窗: 18 months
At least 1 change in frequency of carfilzomib administration.
Reason for change in frequency of concomitant multiple myeloma therapies
时间窗: 18 months
Reason for change in frequency of administration.
次要结局
- Previously received anti-myeloma treatment(18 months)
- Initiation or dose increase of antihypertensive treatment(18 months)
- Initiation or dose increase of existing heart failure treatment(18 months)
- Eastern Cooperative Oncology Group (ECOG) performance status(18 months)
- Cytogenetic risk profile at diagnosis(18 months)
- Number of prior relapses(18 months)
- Response to carfilzomib treatment(18 months)
- Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)(18 months)
- Response to prior treatment(18 months)
- Time to adverse event(18 months)
- Patient age(18 months)
- Decrease in left ventricular ejection fraction (LVEF)(18 months)
- International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation(18 months)
- Presence of comorbidities(18 months)
- Adverse event(18 months)
- Electrocardiogram (ECG) changes(18 months)
- Type of relapse(18 months)
- Patient sex(18 months)
- Patient height(18 months)
- Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation.(18 months)
- Echocardiogram(18 months)
- Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation.(18 Months)
- Number of unplanned hospitalisations(18 months)
- Planned subsequent treatment regimen(18 months)
- ECG (electrocardiogram)(18 months)
- LVEF (left ventricular ejection fraction) assessment(18 months)
- Concomitant therapy not part of the carfilzomib regimen(18 months)
- MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation.(18 months)
- PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation.(18 months)
- Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation.(18 months)
- Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation(18 months)
- Patient weight(18 months)
- Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation.(18 months)
- Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation.(18 months)
- Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation.(18 months)
- Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation.(18 months)