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

NCT05673967 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2025-04-25

No results posted yet for this study

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

OTHER

Non-Interventional

No study treatment will be administered on this study.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2024-09-12
Completion
2025-03-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05673967 on ClinicalTrials.gov