Post-authorisation Observational Study for the Assessment of Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance <50 mL/Min/1.73 m2 (CrCl <50 mL/Min/1.73 m2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 326
- 试验地点
- 40
- 主要终点
- Age of participants at baseline to determinates Renal function response
研究概览
简要总结
A prospective, multicentre, post-authorisation observational study. The objective of this study is assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and CrCl <50 mL/min/1.73 m2.
详细描述
Prospective, multicentre, post-authorisation observational study. Study population: Patients with relapsed multiple myeloma and with CrCl <50 mL/min/1.73 m2, for whom the investigator decides to start a new line of anti-myeloma treatment as per normal clinical practice. The decision to prescribe treatment will be clearly disassociated from the decision to include the patient in the study.
300 patients are expected to be recruited (225 for Group 1 and 75 for Group 2) from 40 sites (approximately 7-8 patients for each site). Patients will be included consecutively in the study.
The inclusion will be stratified to ensure the presence of all stages of renal impairment (RI) in two groups:
Documentation of 300 patients is planned (a maximum of 225 in group 1 and a minimum of 75 in group 2) at 40 sites (approximately 7-8 patients per each site). The patients will be included in the study in a consecutive manner.
In order to ensure the correct stratification of the sample group a real time central registry will be kept for the patients included in each group. Once the required number of patients for one of the groups is completed, inclusion in that group will be closed at all sites, keeping inclusion for other groups open, and so on until the entire sample size is complete.
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 of both genders, aged equal or more than 18 years.
- •Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.
- •Patients with documented renal damage defined as creatinine clearance <50 ml / min / 1.73 m2 (CrCl <50ml / min / 1.73m2).
- •Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice *.
- •Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).
- •Subject with any of the following characteristics (at least one of the 2 following options must be Yes):
- •Subjects who have not previously participated in the study
- •Subjects who have previously participated in the study, who meet all the inclusion criteria again and to whom none of the exclusion criteria apply, and whose current relapse is consecutive to the relapse that prompted their initial inclusion in the study.
- •The decision to prescribe treatment will be clearly dissociated from the decision to include the patient in the study
- •Clarification is provided as to the aim of the study, which is to encompass all relapse subcategories included in the International Myeloma Working Group consensus document published in
- •Therefore, all patients with clinically relapsed multiple myeloma, who are in relapse following a complete response or in progression (including refractory cases) as defined in point 8.1 and in table 4 of the protocol, are considered eligible candidates for participation in the EPA-MIR 50 study, as long as they meet all the other criteria
排除标准
- •Patients who are participating in an interventional clinical trial * or who refuse to participate in the study.
- •Patients with CrCl <50 ml / min / 1.73m2 due to a cause other than multiple myeloma properly documented at the discretion of the investigator *.
- •The inclusion of patients who are participating in another observational study is permitted.
结局指标
主要结局
Age of participants at baseline to determinates Renal function response
时间窗: Baseline visit
Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.
Creatinine levels to determinates Renal function response
时间窗: Up to 12 months
Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Gender of participants at baseline to determinates Renal function response
时间窗: Baseline visit
Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Weight of participants at baseline to determinates Renal function response
时间窗: Baseline visit
Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
次要结局
- Renal response rate assessment in clinical practice.(Up to 12 months)
- Time dependent Renal response rate assessment in clinical practice.(Up to 12 months)
- MM response to Time to Progression(Up to 12 months)
- MM response to Time to first response(Up to 12 months)
- MM response to Progression Free Survival(Up to 12 months)
- Cost of visit to hospital/primary health care associated with anti-myeloma therapy(Up to 12 months)
- Race of participants at Baseline(Baseline visit)
- Clinical Outcome of participants with Multiple Myeloma (MM) clinical description(Up to 12 months)
- Type of Anti-myeloma therapeutic regimens.(Up to 12 months)
- Multiple Myeloma (MM) response to anti-myeloma treatment(Up to 12 months)
- Adverse events (AEs)(Up to 12 months)
- Number of participants with relapsed kidney function(Up to 36 months)