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

NCT05673967 | Completed DMC

• 1 other identifier: R5458-ONC-21101
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

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)

Outcome Measures

Primary Outcomes (2)

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

  Distribution of treatment regimens

  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)

  Up to 6 years

Secondary Outcomes (4)

• Duration of response (DOR)

  Up to 6 years

• Progression-free survival (PFS)

  Up to 6 years

• Overall survival (OS)

  Up to 6 years

• Time to next treatment (TTNT)

  Up to 6 years

Study Arms (1)

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

Non-Interventional OTHER

No study treatment will be administered on this study.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Research Facility

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: January 9, 2023
• Primary Completion: September 12, 2024
• Study Completion: March 28, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (1)