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CompletedNCT05673967Updated Apr 25, 2025

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

An observational study in Relapsed and Refractory Multiple Myeloma (RRMM), sponsored by Regeneron Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Regeneron Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
62
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Relapsed and Refractory Multiple Myeloma (RRMM)

Keywords

  • Real-World Outcomes
  • Multiple Myeloma (MM)
  • Objective response rate (ORR)
  • Triple-class exposed (TCE)
  • Triple-class refractory (TCR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 744 are open to participants now.

This study's enrollment of 62 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR).

Inclusion criteria

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at baseline
  2. Confirmed diagnosis of active MM by IMWG diagnostic criteria
  3. Have myeloma that is response-evaluable with measurable disease by M-protein in serum or urine as specified in the IMWG response criteria.
  4. Triple-class exposed or refractory

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin (POEMS) changes syndrome
  2. Known MM brain lesions or meningeal involvement
  3. History of neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure
  4. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) (or a diagnosis of congestive heart failure, cardiomyopathy, or valvular heart disease as a potential proxy)
  5. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent
  6. Live or live attenuated vaccines
  7. Treated with B-cell maturation antigen (BCMA)-directed immunotherapies (BCMA antibody-drug conjugates are not excluded).

Note: Other protocol-defined Inclusion/Exclusion criteria apply

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Real-world (RW) patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR), meet similar inclusion/exclusion criteria used to establish phase 2 cohort 2 of the R5458-ONC-1826 trial, and are initiating currently available therapies.

    Other: Non-Interventional

Interventions

  • OtherNon-Interventional

    No study treatment will be administered on this study.

06

What researchers measure

Primary outcomes

  1. Proportion of patients exposed to each type of regimen by line of therapy (LOT)

    Distribution of treatment regimens

    Time frame: Up to 6 years

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Overall survival (OS)

    OS is measured from the start of study treatment until death due to any cause.

    Time frame: Up to 6 years

  4. 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

07

Study locations

1 site
  • Regeneron Research Facility
    Tarrytown, New York 10591, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05673967
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 6, 2023
Start date
Jan 9, 2023
Primary completion
Sep 12, 2024
Completion
Mar 28, 2025
Last update
Apr 25, 2025

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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