Post-authorisation Observational Registry to Assess the Clinical Impact of Initiating Anti-tumour Rescue Therapy in Patients With Multiple Myeloma (MM) in Asymptomatic Biological Relapse Compared to Initiating Treatment at the Time of Symptomatic Relapse.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 415
- 试验地点
- 44
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
Post-authorisation prospective follow-up study to assess the clinical impact on time to progression (TTP) from the start of anti- multiple myeloma treatment at the onset of asymptomatic relapse/biological progression versus start of treatment at the time of symptomatic relapse.
详细描述
National, observational, prospective, post-authorisation multicentre registry.
It will include patients with a diagnosis of MM who have received no more than two lines of treatment and with at least one partial relapse (≥ PR) with their latest anti-MM treatment, duly documented in accordance with the criteria of the IMW Consensus Panel 1:
- Patients prior to relapse/biological progression, even without being in asymptomatic relapse/biological progression are followed every one or two months at most, according to the clinical judgment of the physician investigator, and provided there is an analysis (proteinogram and/or immunofixation) in the two months (+/- 15 days) prior to inclusion in which it can be documented that the patient was not in a situation of asymptomatic relapse or progression.
Patients in first or second relapse/biological progression who initiate any of the treatments currently approved and marketed in Spain for the treatment of relapsed MM, based on the criteria of the International Myeloma Workshop (IMW) Consensus Panel 11 or patients without treatment from relapse/biological progression to clinical relapse who initiate treatment after clinical relapse, according to standard criteria for clinical practice, and according to the clinical decision of each participating physician in the study, and provided there is an analysis (proteinogram and/or immunofixation) in the two months (+/- 15 days) prior to inclusion in which it can be documented that the patient was not in a situation of relapse or asymptomatic progression.
Therefore, two groups are defined for inclusion in the registry for patients in 1st or 2nd relapse/biological progression, depending on the treatment strategy adopted according to the routine clinical practice of each site participating in the study.
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
- •Male or female, greater than or equal to 18 years of age patients with a diagnosis of Multiple Myeloma (MM) based on the international criteria.
- •Patients with a diagnosis of Multiple Myeloma who had not received more than two regimen therapies and who had achieved at least a Partial Response (PR) with the last anti- Multiple Myeloma treatment according the criteria of the IMW (International Myeloma Workshop) Consensus Panel 1, included before relapse/biological progression or with an asymptomatic relapse (without Calcium increase, Renal Impairment, Anemia and Bone Lesion (CRAB) symptoms) defined by a ≥25% increase on the lowest value obtained during remission, in any of the following:
- •Serum M-protein (absolute increase must be ≥05 g/dL) and/or
- •Urine M-component (absolute increase must be ≥ 200 Mg/24 hrs.), and/or
- •Only for patients without measurable components in serum and urine, a 25% increase on the lowest difference in Free light chain (FLC) ratios (absolute increase >10 mg/dL)
- •In patients with unmeasurable M-protein in serum and urine, and unmeasurable FLC levels, a 25% increase in the percentage of plasma cells in bone marrow (the absolute percentage must be ≥10%) In any case, it is necessary to have an analysis (proteinogram and/or immunofixation) in the two months (+/- 15 days) prior to inclusion in which it can be documented that the patient was not in a situation of relapse or asymptomatic progression.
- •Patients with an asymptomatic relapse/progression from a Complete Response (CR):
- •Reappearance of serum or urine M-protein by immunofixation or electrophoresis
- •Patients who consent in writing after they has clearly explained the nature and purpose of the study (consent written informed).
排除标准
- •Patients who are participating in an interventional clinical trial.
- •Patients that refuse to participate in the study.
- •Patients who present physical or mental incapacity to understand the information that is supplied, and/or respond to questions their doctor will perform as part of the study.
- •Clinical Relapse Criteria
结局指标
主要结局
Time to progression (TTP)
时间窗: Up to 38 months
The period from when relapse/biological progression is detected until a new relapse or progression of tumour to the treatment received for biological or clinical relapse is documented according to the criteria of the IMW Consensus Panel.
次要结局
- The time from biological progression until clinical relapse(Up to 38 months)
- Race of participants at Baseline(Baseline visit)
- Overall survival (OS)(Up to 38 months)
- Concomitant treatments related to MM(Baseline visit)
- ECOG performance status(Baseline visit)
- Define the abnormal findings within the Biochemistry panel(Baseline visit)
- Event-free survival (EFS)(Up to 38 months)
- Age of participants at Baseline(Baseline visit)
- Time from first pathologic diagnosis(Baseline visit)
- The number of Comorbidities(Baseline visit)
- Define the abnormal finding in complete blood count at base line(Baseline visit)
- Overall Response rate(Up to 38 months)
- Progression-free survival (PFS)(Up to 38 months)
- QLQ-MY24 Questionnaire(Up to 38 months)
- Adverse Events (AEs)(Up to 38 months)
- Gender of participants at Baseline(Baseline visit)
- Stage of Multiple Myeloma (MM) before study entry based on the international staging system (ISS)(Baseline visit)
- EORTC QLQ-C30 Questionnaire(Up to 38 months)
- Cost associated with participants visit to hospital/primary health care associated with anti-myeloma therapy(Up to 38 months)