Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 22
- 试验地点
- 12
- 主要终点
- Number of Adverse events of special interest during Len/Dex therapy
研究概览
简要总结
Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC).
详细描述
This study aims to assess the real-life safety of Lenalidomide/Dexamethasone (Len/Dex) in patients with (Relapsed or Refractory Multiple Myeloma (rrMM), by evaluation of adverse events of special interest (infections, gastrointestinal events, thrombocytopenia, neutropenia, febrile neutropenia, and thromboembolism). In addition, due to the scarce information regarding the impact of frailty in Len/Dex treatment in rrMM, this study will prospectively assess Len/Dex safety and effectiveness by patient frailty groups.
The following study assessments will be performed:
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Recruitment: patients will be recruited within 15 days after the start of Len/Dex (from day 1 to day 15). In case patients are not recruited at the day of Len/Dex start (day 1), baseline information respective to this day will be collected retrospectively.
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Treatment period: during this period, the following assessments will be carried out:
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Every 30 days (± 5 days) for adverse events, changes in concomitant medication and change in Len/Dex dose.
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Every 90 days (± 15 days) for the remaining information to be collected in the treatment period
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Assessment at the end of Len/Dex treatment (until 5 days after end of treatment).
Follow-up assessment 90 days (± 15 days) after the end of Len/Dex treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged 18 years or higher.
- •Patients who have voluntarily given written informed consent to participate in the study and have their data retrieved for the purposes of the study
- •Patients diagnosed with 1st or 2nd relapsed or refractory multiple myeloma and indicated for 2nd or 3rd line Len/Dex treatment, according with the SmPC (patients who have received at least one prior therapy) -
排除标准
- •Pregnant or lactating patients
- •Female patients of childbearing potential unable or unwilling to use effective contraceptive methods, as stated in the summary of product characteristics:
- •Levonorgestrel-releasing intrauterine system.
- •Medroxyprogesterone acetate depot.
- •Tubal sterilisation.
- •Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses.
- •Ovulation inhibitory progesterone-only pills (i.e. desogestrel).
- •Male patients unable to follow or comply with the required contraceptive measures stated in the SmPC (use of condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception [even if the man has had a vasectomy], during treatment and for 1 week after dose interruptions and/or cessation of treatment)
- •Hypersensitivity to the active substance or any of the excipients
- •Patients participating in a clinical trial -
研究组 & 干预措施
Lenalidomide/Dexamethasone
Standard of Care doses for relapsed/refractory multiple myeloma
干预措施: Lenalidomide (Drug)
Lenalidomide/Dexamethasone
Standard of Care doses for relapsed/refractory multiple myeloma
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Adverse events of special interest during Len/Dex therapy
时间窗: Up to approximately 72 months
Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, i.e. any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Progression of the underlying disease of multiple myeloma is not considered an AE and should not be reported as an AE
次要结局
- Incidence (number) of thromboembolism(Up to approximately 72 months)
- Duration of Len/Dex treatment over the course of the study(Up to approximately 72 months)
- Number of patients with good and poor compliance to lenalidomide and dexamethasone(Up to approximately 72 months)
- Type and frequency of prophylaxis treatment for prevention of thromboembolism(Up to 36 months)