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NCT02990338 · ClinicalTrials.gov registry record · Phase 3
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 307
- Enrollment target
NCT02990338 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 307 participants.
The verdict
NCT02990338, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 307 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: * To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. * To compare the Overall Survival (OS) between the two arms. * To evaluate the Time To Progression (TTP) in each arm. * To evaluate the PFS in high risk cytogenetic population in each arm. * To evaluate the Duration of Response (DOR) in each arm. * To evaluate the safety in both treatment arms. * To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. * To evaluate the immunogenicity of isatuximab. * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Isatuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2016-12-22 |
| Est. Completion | 2023-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02990338
The ClinicalTrials.gov registry entry for NCT02990338 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 307 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.
NCT02990338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02990338 about?
NCT02990338 is a clinical study titled "Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients". Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple m...
What is the current status of trial NCT02990338?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2016-12-22. Estimated completion is 2023-11-01.
What interventions are being tested in trial NCT02990338?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab (DRUG).
Who is sponsoring clinical trial NCT02990338?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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