Calendario›REGN›Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma
Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma
Ensayo de REGENERON PHARMACEUTICALS, INC. en Relapsed and Refractory Multiple Myeloma (RRMM) (del registro, en inglés).
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 62
- Centros
- 1
- Fin del objetivo primario
- sep 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en ene 2023.
Qué mide
Proportion of patients exposed to each type of regimen by line of therapy (LOT) (del registro, en inglés) (hasta 6 años)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: 1\. To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and are triple-class exposed (TCE), or (b) are triple-class refractory (TCR), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial. Secondary Objectives: 1. To describe additional outcomes (duration of response \[DOR\], progression-free survival \[PFS\], overall survival \[OS\], and time to next treatment \[TTNT\]) in the same Benchmark Cohort population described in the primary objective. 2. To describe distribution of treatment regimens, ORR, DOR, PFS, OS, and to compare ORR, PFS, OS, and TTNT in an Analysis Cohort consisting of real-world patients derived from the Benchmark Cohort described above who are weighted to align with the characteristics of patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial. Comparative analyses of PFS and OS will be performed conditional on sufficient maturity of survival data in the R5458-ONC-1826 (NCT03761108) trial at the time of analysis.
Más ensayos de REGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| cemiplimab | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Pozelimab + Cemdisiran · NIMBLE | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Garetosmab · OPTIMA | Fase 3 | En marcha, sin reclutar | jul 2025 (real) |
| Aflibercept 8 mg · ELARA | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Dupilumab · ENGAGE | Fase 2 | En marcha, sin reclutar | feb 2026 (real) |
| Fianlimab | Fase 3 | En marcha, sin reclutar | mar 2026 (real) |
Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05673967), actualizada en abr 2025.