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NCT05673967 · ClinicalTrials.gov registry record
Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma
A clinical trial, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- 62
- Enrollment target
NCT05673967: Completed study, sponsored by Regeneron Pharmaceuticals.
NCT05673967 is a clinical trial that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05673967 has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- 62 participants
- Enrollment target
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.
Primary Outcome
Distribution of treatment regimens
Interventions
- OTHER Non-Interventional
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2025-03-28 |
What the finished NCT05673967 record still lists
NCT05673967 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Non-Interventional is the first listed.
NCT05673967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05673967 about?
NCT05673967 is a clinical study titled "Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma". 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 p...
What is the current status of trial NCT05673967?
This trial is currently completed. The enrollment target is 62 participants. The study started on 2023-01-09. Estimated completion is 2025-03-28.
What interventions are being tested in trial NCT05673967?
The interventions under investigation include: Non-Interventional (OTHER).
Who is sponsoring clinical trial NCT05673967?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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