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NCT04045795 · ClinicalTrials.gov registry record · Phase 1
Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT04045795 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 56 participants.
The verdict
NCT04045795, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
Primary Objectives: * To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) * To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device * To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: * To estimate absolute bioavailability of SC and IV isatuximab * To measure receptor occupancy (RO) after isatuximab SC versus IV administration * To assess efficacy of isatuximab after SC and IV administration * To assess patient expectations prior to and patient experience and satisfaction after SC administration * To evaluate potential immunogenicity of SC or IV isatuximab
Interventions
- DRUG dexamethasone
- DRUG pomalidomide
- DRUG isatuximab SAR650984 IV
- DRUG isatuximab SAR650984 SC
- DEVICE Investigational injector device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-08-06 |
| Est. Completion | 2024-03-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04045795
The ClinicalTrials.gov registry entry for NCT04045795 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 0 conditions, and to 5 interventions - of which dexamethasone is the first listed.
NCT04045795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04045795 about?
NCT04045795 is a clinical study titled "Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)". Primary Objectives: * To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) * To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device * To eval...
What is the current status of trial NCT04045795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2019-08-06. Estimated completion is 2024-03-27.
What interventions are being tested in trial NCT04045795?
The interventions under investigation include: dexamethasone (DRUG), pomalidomide (DRUG), isatuximab SAR650984 IV (DRUG), isatuximab SAR650984 SC (DRUG), Investigational injector device (DEVICE).
Who is sponsoring clinical trial NCT04045795?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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