再発性および/または難治性多発性骨髄腫（RRMM）患者を対象としたイサツキシマブを用いた前向き非介入多国籍観察研究
基本情報
- NCT ID
- NCT04458831
- ステータス
- 実施中（募集終了）
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 583
- 治験依頼者名
- Sanofi
概要
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