Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active study of Plasma Cell Myeloma, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria
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 |
What the registry record for NCT04458831 still lists
NCT04458831 is an observational study that tracks outcomes without assigning an intervention. The registered 583 participants enrollment target is mid-sized for trials with a published cap, above the 190-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (207% higher).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Plasma Cell Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04458831's enrollment target sits among peer trials
583 3rd of 32 higher than 30 of 32 other Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plasma Cell Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial
RECRUITING · Phase 3
-
Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma
RECRUITING · Phase 2
-
Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
RECRUITING · Phase 1
-
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
RECRUITING · Phase 3
-
Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
RECRUITING · NA
-
Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03840083 · 584 participants · NA
Sleep-dependent Learning in Aging
- NCT04984291 · 584 participants · NA
Zimmer Biomet Shoulder Arthroplasty PMCF
- NCT05983757 · 584 participants · NA
Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe
- NCT06569290 · 584 participants · NA
Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI