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NCT04458831 · ClinicalTrials.gov registry record
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
A clinical trial of Plasma Cell Myeloma, sponsored by Sanofi.
- Active
- Registry status
- 583
- Enrollment target
- 20
- Study locations
NCT04458831 is a study of Plasma Cell Myeloma that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 583 participants, above the 190-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (207% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT04458831, a study of Plasma Cell Myeloma, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- 583 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Carfilzomib
- DRUG isatuximab SAR650984
Study Locations (20)
Florida
- Holy Cross Hospital Site Number : 8400030 - Fort Lauderdale
- GenesisCare Site Number : 8400007 - Jacksonville
- Watson Clinic Cancer and Research Center Site Number : 8400023 - Lakeland
- Millennium Oncology Site Number : 8400025 - Pembroke Pines
- Comprehensive Hematology Oncology Site Number : 8400026 - St. Petersburg
New Jersey
- Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017 - Freehold
- Regional Cancer Care Associates Site Number : 8400024 - Howell Township
- Regional Cancer Care Associates - Little Silver Division Site Number : 8400018 - Little Silver
California
- St. Joseph Heritage Healthcare Site Number : 8400008 - Fullerton
- University of California San Francisco (PARENT) Site Number : 8400009 - San Francisco
Missouri
- Central Care Cancer Center Site Number : 8400006 - Garden City
- AMR Kansas City Site Number : 8400016 - Kansas City
Ohio
- Hematology & Oncology Associates Site Number : 8400015 - Canton
- Tri County Hematology & Oncology Associates, Inc Site Number : 8400012 - Massillon
Arkansas
- University of Arkansas Medical Sciences Site Number : 8400021 - Little Rock
Kansas
- Central Care Cancer Center Site Number : 8400019 - Garden City
Maine
- Central Maine Medical Center Site Number : 8400031 - Lewiston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 583 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2026-02-23 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04458831
The ClinicalTrials.gov registry entry for NCT04458831 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 583 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 190-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (207% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Plasma Cell Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT04458831 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, New Jersey, California.
Frequently Asked Questions
What is clinical trial NCT04458831 about?
NCT04458831 is a clinical study titled "A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)". 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), tim...
What is the current status of trial NCT04458831?
This trial is currently active not recruiting. The enrollment target is 583 participants. The study started on 2020-08-13. Estimated completion is 2026-02-23.
What conditions does trial NCT04458831 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma.
What interventions are being tested in trial NCT04458831?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Carfilzomib (DRUG), isatuximab SAR650984 (DRUG).
Who is sponsoring clinical trial NCT04458831?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04458831 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Kansas, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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