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.
Study Type
OBSERVATIONAL
Enrollment
62
No study treatment will be administered on this study.
Regeneron Research Facility
Tarrytown, New York, United States
Proportion of patients exposed to each type of regimen by line of therapy (LOT)
Distribution of treatment regimens
Time frame: Up to 6 years
Proportion of patients with objective response rate (ORR)
Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)
Time frame: Up to 6 years
Duration of response (DOR)
Defined as time from the date of the first documented response (best overall response of sCR, CR, VGPR, PR) until the first date of progressive disease (PD) by International Myeloma Working Group (IMWG) or death due to any cause, whichever occurs first.
Time frame: Up to 6 years
Progression-free survival (PFS)
Defined as time from the start of study treatment until the first date of PD by IMWG, or death due to any cause, whichever occurs first.
Time frame: Up to 6 years
Overall survival (OS)
OS is measured from the start of study treatment until death due to any cause.
Time frame: Up to 6 years
Time to next treatment (TTNT)
Defined as time from the start of study treatment until the initiation of the subsequent LOT.
Time frame: Up to 6 years
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