A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 583
- 试验地点
- 129
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
Primary Objective:
To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months
To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice
To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice
To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)
To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)
Secondary Objective:
Not applicable
详细描述
Duration per participant is 2.5 years
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
- •Age ≥18 years or country's legal age of majority if the legal age is >18 years old at the time of enrollment
- •Patients with RRMM who have at least one prior line of therapy
- •Patients for whom the treating physician has made the decision to initiate isatuximab per routine practice and independently of the purpose of the study; for retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of three months prior to study enrollment
- •Able to understand and complete the study-related questionnaires
- •Patient must have given signed informed consent prior to study start. For retrospectively enrolled patients who are deceased at the date of enrollment into the study, a waiver of consent will be required; patients who have started and stopped treatment or whose treatment is still ongoing at ICF are eligible
- •Most important
排除标准
- •for potential participants:
- •Patients who are receiving isatuximab for an indication other than RRMM
- •Patients who have received any other investigational drug or prohibited therapy for this study within 28 days or five half-lives from randomization, whichever is longer
- •Patients having contraindication to the isatuximab summary of product characteristics (SMPC) or package insert (PI)
- •Patients having contraindications as noted in the drug-specific local isatuximab SMPC/PI of combination drugs
- •Any country-related specific regulation that would prevent the patient from entering the study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Further eligibility criteria might apply.
研究组 & 干预措施
Cohort 1
Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
干预措施: isatuximab SAR650984 (Drug)
Cohort 1
Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
干预措施: Dexamethasone (Drug)
Cohort 1
Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
干预措施: Pomalidomide (Drug)
Cohort 1
Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
干预措施: Carfilzomib (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 12 months
The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria
Progression free survival (PFS)
时间窗: Up to 30 months
Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first.
Progression free survival rate (PFSR)
时间窗: up to 18 months
The proportion of patients who do not progress and are alive at a specific time intervals
Duration of response (DoR)
时间窗: Up to 30 months
Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR, VGPR, CR, or sCR) to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first.
Time to response (TTR)
时间窗: Up to 30 months
Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria
Time to first subsequent anti-myeloma therapy
时间窗: Up to 30 months
Time from the initiation of isatuximab until the start of subsequent therapy or death.
Rate of very good partial response or better
时间窗: 12 months
Comprising VGPR, CR, and sCR within 12 months
Rate of complete response (CR) or better
时间窗: 12 months
Comprising CR and sCR responses within 12 months
Number of Participants with Adverse events
时间窗: Up to 1 month after the end of treatment
Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: infusion associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second primary malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30)
时间窗: through end of treatment (up to approximately 2 years)
EORTC QLQ-MY20 standardized scores: The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact.
Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)
时间窗: through end of treatment (up to approximately 2 years)
EORTC QLQ-C30 standardized scores: The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).
次要结局
未报告次要终点