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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 is a clinical trial that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 62 participants.
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.
Interventions
- OTHER Non-Interventional
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2025-03-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05673967
The ClinicalTrials.gov registry entry for NCT05673967 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Non-Interventional is the first listed.
NCT05673967 reports 0 study locations.
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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