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NCT02283775 · ClinicalTrials.gov registry record · Phase 1
SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02283775: Completed Phase 1 study, sponsored by Sanofi.
NCT02283775 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02283775, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: * To evaluate the infusion duration (Part B). * To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). * To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). * To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). * To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). * To assess the relationship between clinical effects (adverse event \[AE\] and/or tumor response) and CD38 receptor density at baseline (Part A).
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Isatuximab SAR650984
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-05-15 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 1 |
What the finished NCT02283775 record still lists
NCT02283775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02283775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02283775 about?
NCT02283775 is a clinical study titled "SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients". Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed i...
What is the current status of trial NCT02283775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2015-05-15. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT02283775?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab SAR650984 (DRUG).
Who is sponsoring clinical trial NCT02283775?
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 NCT02283775's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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