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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 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. The trial reports 20 study locations across 8 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04643002
The ClinicalTrials.gov registry entry for NCT04643002 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 Refractory appearing as the primary indexed condition, and to 5 interventions - of which Belantamab mafodotin is the first listed.
NCT04643002 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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