Trials / Completed
CompletedNCT03275285
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.
Detailed description
The duration of the study for a patient will include a period for screening of up to 3 weeks. Patients will be treated until disease progression, unacceptable AE, or patient decision to stop the study treatment. After study treatment discontinuation, patients will have follow-up visits until the analysis of overall survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isatuximab SAR650984 | Pharmaceutical form: solution for infusion Route of administration: intravenous |
| DRUG | carfilzomib | Pharmaceutical form: solution for infusion Route of administration: intravenous |
| DRUG | dexamethasone | Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous |
Timeline
- Start date
- 2017-10-25
- Primary completion
- 2022-01-14
- Completion
- 2025-01-03
- First posted
- 2017-09-07
- Last updated
- 2026-02-09
- Results posted
- 2023-02-13
Locations
70 sites across 16 countries: United States, Australia, Brazil, Canada, Czechia, France, Greece, Hungary, Italy, Japan, New Zealand, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03275285. Inclusion in this directory is not an endorsement.