Trials / Active Not Recruiting
Active Not RecruitingNCT04458831
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 583 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
Detailed description
Duration per participant is 2.5 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isatuximab SAR650984 | Pharmaceutical form: solution for infusion Route of administration: intravenous |
| DRUG | Pomalidomide | Pharmaceutical form: oral |
| DRUG | Dexamethasone | Pharmaceutical form: oral |
| DRUG | Carfilzomib | Pharmaceutical form: solution for infusion |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2026-02-23
- Completion
- 2026-02-23
- First posted
- 2020-07-07
- Last updated
- 2025-06-27
Locations
129 sites across 21 countries: United States, Argentina, Austria, Belgium, China, France, Germany, Greece, Hong Kong, Italy, Japan, Kuwait, Netherlands, Puerto Rico, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom
Source: ClinicalTrials.gov record NCT04458831. Inclusion in this directory is not an endorsement.