NCT05673967

Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma

A Study to Characterize Treatment Patterns and Real-World Outcomes in Heavily Pretreated Patients With Relapsed and Refractory Multiple Myeloma (RRMM) and Similar Clinical Characteristics to Patients in the Phase 2 Cohort 2 of the R5458-ONC-1826 Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary 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.

Conditions

• Relapsed and Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
OTHER	Non-Interventional	No study treatment will be administered on this study.

Timeline

• Start date: 2023-01-09
• Primary completion: 2024-09-12
• Completion: 2025-03-28
• First posted: 2023-01-06
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States