A Prospective Non-interventional Multinational Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
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- STATUS
- Recruiting
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- End date
- Oct 12, 2025
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- participants needed
- 1300
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- sponsor
- Sanofi
Summary
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)
Secondary Objective:
Not applicable
Description
Duration per participant is 2.5 years
Details
| Condition | Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder, lymphoproliferative disorders, lymphoproliferative disorders |
|---|---|
| Age | 18years - 100years |
| Treatment | Isatuximab SAR650984 |
| Clinical Study Identifier | NCT04458831 |
| Sponsor | Sanofi |
| Last Modified on | 12 November 2020 |
Eligibility
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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