A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Completed
Conditions studied: Plasma Cell Myeloma
In brief
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
Key facts
- Study ID
- NCT04458831
- Run by
- Sanofi
- People needed
- 583
- Starts
- 2020-08-13
- Expected to finish
- 2026-02-23
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Watson Clinic Cancer and Research Center Site Number : 8400023 — Lakeland, Florida, United States
- Millennium Oncology Site Number : 8400025 — Pembroke Pines, Florida, United States
- Comprehensive Hematology Oncology Site Number : 8400026 — St. Petersburg, Florida, United States
- Central Care Cancer Center Site Number : 8400019 — Garden City, Kansas, United States
- Central Maine Medical Center Site Number : 8400031 — Lewiston, Maine, United States
- Michigan Center of Medical Research Site Number : 8400010 — Farmington Hills, Michigan, United States
- Central Care Cancer Center Site Number : 8400006 — Garden City, Missouri, United States
- AMR Kansas City Site Number : 8400016 — Kansas City, Missouri, United States
- Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017 — Freehold, New Jersey, United States
- Regional Cancer Care Associates Site Number : 8400024 — Howell Township, New Jersey, United States
- Regional Cancer Care Associates - Little Silver Division Site Number : 8400018 — Little Silver, New Jersey, United States
- Novant Health Forsyth Medical Center Site Number : 8400028 — Winston-Salem, North Carolina, United States
- Hematology & Oncology Associates Site Number : 8400015 — Canton, Ohio, United States
- Tri County Hematology & Oncology Associates, Inc Site Number : 8400012 — Massillon, Ohio, United States
- Charleston Hematology Oncology Associates, PA Site Number : 8400020 — Charleston, South Carolina, United States
- Prisma Health - Eastside Office Site Number : 8400011 — Greenville, South Carolina, United States
- Prairie Lakes Health Care System, Inc Site Number : 8400002 — Watertown, South Dakota, United States
- MD Anderson Cancer Center Site Number : 8400013 — Houston, Texas, United States
- Renovatio Clinical Site Number : 8400004 — The Woodlands, Texas, United States
- Investigational Site Number : 0320001 — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
- Investigational Site Number : 0320006 — Pilar, Buenos Aires, Argentina
- Investigational Site Number : 0320004 — Buenos Aires, Argentina
- Investigational Site Number : 0320005 — Córdoba, Argentina
- Investigational Site Number : 0320002 — Córdoba, Argentina
- GenesisCare Site Number : 8400007 — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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