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NCT02514668 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT02514668: Completed Phase 1 study, sponsored by Sanofi.
NCT02514668 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 55 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
NCT02514668, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Primary Objective: * Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). * Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: * Part A: * To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. * Part B: * To evaluate the safety of SAR650984 (isatuximab). * To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). * To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline. * To evaluate the immunogenicity of SAR650984 (isatuximab).
Interventions
- DRUG Isatuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2021-12-02 |
| Phase | Phase 1 |
What the finished NCT02514668 record still lists
NCT02514668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 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 1 intervention - of which Isatuximab is the first listed.
NCT02514668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02514668 about?
NCT02514668 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma". Primary Objective: * Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). * Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. ...
What is the current status of trial NCT02514668?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2015-09-01. Estimated completion is 2021-12-02.
What interventions are being tested in trial NCT02514668?
The interventions under investigation include: Isatuximab (DRUG).
Who is sponsoring clinical trial NCT02514668?
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 NCT02514668's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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