Sanofi OBS16577 A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and / or Refractory Multiple Myeloma (RRMM) - Mercy Medical Center

Sanofi OBS16577 A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and / or Refractory Multiple Myeloma (RRMM)

Posted on: March 9, 2021

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 initiated 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). Eligibility includes being at least 18 years old as well as additional requirements that can be discussed with a clinical trials coordinator upon request

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