A Non-interventional Post Authorisation Registry of Patients Treated With Pomalidomide for Relapsed and Refractory Multiple Myeloma Who Have Received at Least Two Prior Treatment Regimens, Including Both Lenalidomide and Bortezomib, and Have Demonstrated Disease Progression on the Last Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 775
- 试验地点
- 122
- 主要终点
- Determine incidence of risks as outlined in the Risk Management Plan
研究概览
简要总结
This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care.
The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.
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
- •Understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the Registry.
- •Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment.
排除标准
- •Refusal to participate in the Registry or currently participating in the treatment phase of an interventional clinical trial.
- •Women of childbearing potential, unless all the conditions of the pregnancy prevention program are met.
- •Male patients unable to follow or comply with the required contraceptive measures.
- •Hypersensitivity to the active substance or to any of the excipients.
研究组 & 干预措施
Relapsed and Refractory Multiple Myeloma Patients
Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)
干预措施: IMNOVID (Drug)
结局指标
主要结局
Determine incidence of risks as outlined in the Risk Management Plan
时间窗: Up to 3 years
To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated multiple myeloma patients who are currently being treated with IMNOVID (pomalidomide) in a post-marketing setting.
次要结局
- Previous Treatments(Approximately 6 months)
- Pregnancy Prevention Programme Effectiveness(Up to 3 years)