A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Public ClinicalTrials.gov record NCT04458831. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04458831
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 583 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2020
- Primary completion
- Feb 22, 2026
- Completion
- Feb 22, 2026
- Last update posted
- Jul 28, 2026
2020 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas Medical Sciences Site Number : 8400021 | Little Rock | Arkansas | 72205-7199 | — |
| St. Joseph Heritage Healthcare Site Number : 8400008 | Fullerton | California | 92835 | — |
| University of California San Francisco (PARENT) Site Number : 8400009 | San Francisco | California | 94143 | — |
| Holy Cross Hospital Site Number : 8400030 | Fort Lauderdale | Florida | 33308 | — |
| GenesisCare Site Number : 8400007 | Jacksonville | Florida | 32204 | — |
| Watson Clinic Cancer and Research Center Site Number : 8400023 | Lakeland | Florida | 33805 | — |
| Millennium Oncology Site Number : 8400025 | Pembroke Pines | Florida | 33024 | — |
| Comprehensive Hematology Oncology Site Number : 8400026 | St. Petersburg | Florida | 33709 | — |
| Central Care Cancer Center Site Number : 8400019 | Garden City | Kansas | 67846 | — |
| Central Maine Medical Center Site Number : 8400031 | Lewiston | Maine | 04240 | — |
| Michigan Center of Medical Research Site Number : 8400010 | Farmington Hills | Michigan | 48334 | — |
| Central Care Cancer Center Site Number : 8400006 | Garden City | Missouri | 67846 | — |
| AMR Kansas City Site Number : 8400016 | Kansas City | Missouri | 64114 | — |
| Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017 | Freehold | New Jersey | 07728 | — |
| Regional Cancer Care Associates Site Number : 8400024 | Howell Township | New Jersey | 07731 | — |
| Regional Cancer Care Associates - Little Silver Division Site Number : 8400018 | Little Silver | New Jersey | 07739 | — |
| Novant Health Forsyth Medical Center Site Number : 8400028 | Winston-Salem | North Carolina | 27103 | — |
| Hematology & Oncology Associates Site Number : 8400015 | Canton | Ohio | 44708 | — |
| Tri County Hematology & Oncology Associates, Inc Site Number : 8400012 | Massillon | Ohio | 44646 | — |
| Charleston Hematology Oncology Associates, PA Site Number : 8400020 | Charleston | South Carolina | 29414 | — |
| Prisma Health - Eastside Office Site Number : 8400011 | Greenville | South Carolina | 29615 | — |
| Prairie Lakes Health Care System, Inc Site Number : 8400002 | Watertown | South Dakota | 57201-1548 | — |
| MD Anderson Cancer Center Site Number : 8400013 | Houston | Texas | 77030-4000 | — |
| Renovatio Clinical Site Number : 8400004 | The Woodlands | Texas | 77380 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 105 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04458831, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04458831 live on ClinicalTrials.gov.