Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 54 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02283775
The ClinicalTrials.gov registry entry for NCT02283775 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 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 3 interventions - of which Dexamethasone is the first listed.
NCT02283775 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.