Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04643002 · ClinicalTrials.gov registry record · Phase 1
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
A Phase 1 study of Plasma Cell Myeloma Refractory, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 258
- Enrollment target
- 20
- Study locations
NCT04643002: Recruiting Phase 1 study of Plasma Cell Myeloma Refractory, sponsored by Sanofi.
NCT04643002 is a Phase 1 study of Plasma Cell Myeloma Refractory that is actively recruiting participants, run by Sanofi. The registered enrollment target is 258 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (330% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04643002, a Phase 1 study of Plasma Cell Myeloma Refractory, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 258 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.
Primary Outcome
Determination or confirmation of the dose will be based on: safety and tolerability in terms of TEAEs/SAEs, dose-limiting toxicity occurrence, and laboratory parameters available information on PK (if appropriate) and biomarkers.
Conditions Studied
Interventions
- DRUG Belantamab mafodotin
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Isatuximab
- DRUG Pegenzileukin
Study Locations (20)
Other
- Investigational Site Number : 2500002 - Lille
- Investigational Site Number : 2500001 - Nantes
- Investigational Site Number : 2500004 - Paris
- Investigational Site Number : 2500003 - Paris
- Investigational Site Number : 2760006 - Frankfurt
- Investigational Site Number : 2760008 - Lübeck
- Investigational Site Number : 3000002 - Athens
- Investigational Site Number : 3000001 - Athens
- Investigational Site Number : 3760002 - Jerusalem
- Investigational Site Number : 3760003 - Ramat Gan
- Investigational Site Number : 3760001 - Tel Aviv
- Investigational Site Number : 5780001 - Oslo
Victoria
- Investigational Site Number : 0360002 - Melbourne
- Investigational Site Number : 0360001 - Richmond
Georgia
- Winship Cancer Institute, Emory University- Site Number : 8400010 - Atlanta
Illinois
- University of Illinois-Chicago - College of Medicine- Site Number : 8400007 - Chicago
Michigan
- University of Michigan Health System - Ann Arbor- Site Number : 8400004 - Ann Arbor
New York
- Roswell Park Cancer Institute- Site Number : 8400008 - Buffalo
New South Wales
- Investigational Site Number : 0360006 - Wollongong
Reggio Emilia
- Investigational Site Number : 3800001 - Meldola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2028-04-20 |
| Phase | Phase 1 |
What NCT04643002 shows while recruiting
NCT04643002 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (330% higher).
The record links to 1 condition, with Plasma Cell Myeloma Refractory appearing as the primary indexed condition, and to 5 interventions - of which Belantamab mafodotin is the first listed.
NCT04643002 names 20 study sites across 8 states, led by Other, Victoria, Georgia.
Frequently Asked Questions
What is clinical trial NCT04643002 about?
NCT04643002 is a clinical study titled "Isatuximab in Combination With Novel Agents in RRMM - Master Protocol". The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 ...
What is the current status of trial NCT04643002?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 258 participants. The study started on 2021-01-25. Estimated completion is 2028-04-20.
What conditions does trial NCT04643002 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma Refractory.
What interventions are being tested in trial NCT04643002?
The interventions under investigation include: Belantamab mafodotin (DRUG), Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab (DRUG), Pegenzileukin (DRUG).
Who is sponsoring clinical trial NCT04643002?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04643002 being conducted?
This trial has 20 study locations across Georgia, Illinois, Michigan, New York, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Plasma Cell Myeloma Refractory
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 NCT04643002's enrollment target sits among peer trials
258 167th of 2000 higher than 1,833 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
-
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
RECRUITING · Phase 1
-
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
RECRUITING · Phase 2
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
- NCT03785288 · 258 participants · Phase 3
Vaginal Cuff Brachytherapy Fractionation Study
- NCT04924322 · 258 participants · Phase 2
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
- NCT05043012 · 258 participants · NA
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
- NCT05482893 · 258 participants · Phase 1
Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
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