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Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
NCT04643002 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04643002 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Victoria, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04643002?
The interventions under investigation include: Belantamab mafodotin (DRUG), Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab (DRUG), Pegenzileukin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04643002?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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