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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: Completed Phase 1 study, sponsored by Sanofi.
NCT04045795 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of participants with adverse events
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 |
What the finished NCT04045795 record still lists
NCT04045795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which dexamethasone is the first listed.
NCT04045795 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04045795's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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
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