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OpenTrials
Completed

NCT Number: NCT05673967

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 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.

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Key information

Conditions

Relapsed and Refractory Multiple Myeloma (RRMM) Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Research Facility

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Known MM brain lesions or meningeal involvement
  • History of neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure
  • 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)
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent
  • Live or live attenuated vaccines
  • Treated with B-cell maturation antigen (BCMA)-directed immunotherapies (BCMA antibody-drug conjugates are not excluded).

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Treatment and study plan

Non-Interventional

Other

No study treatment will be administered on this study.

Primary outcomes

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

    Time frame: Up to 6 years

    Distribution of treatment regimens

  2. Proportion of patients with objective response rate (ORR)

    Time frame: Up to 6 years

    Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)

Secondary outcomes

  1. Duration of response (DOR)

    Time frame: Up to 6 years

    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.

  2. Progression-free survival (PFS)

    Time frame: Up to 6 years

    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.

  3. Overall survival (OS)

    Time frame: Up to 6 years

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

  4. Time to next treatment (TTNT)

    Time frame: Up to 6 years

    Defined as time from the start of study treatment until the initiation of the subsequent LOT.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Study to Characterize Treatment Patterns and Real-World Outcomes in Heavily Pretreated Patients With Relapsed and Refractory Multiple Myeloma (RRMM) and Similar Clinical Characteristics to Patients in the Phase 2 Cohort 2 of the R5458-ONC-1826 Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 6, 2023
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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