REGN5458 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple Myeloma+1 More
REGN5458 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, REGN5458, for patients with relapsed or refractory multiple myeloma who have progressed on or after 3 prior lines of therapy or who are triple-refractory. The primary objectives are to assess the safety and tolerability of REGN5458 and to determine the recommended phase 2 dose. The secondary objectives are to assess the anti-tumor activity of REGN5458, evaluate the effects of REGN5458 on health-related quality of life, and characterize the immunogenicity of REGN5458.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

5 Primary · 19 Secondary · Reporting Duration: Up to 5 years

Year 5
Change in patient-reported Global health status/QoL per EORTC QLQ-C30
Change in patient-reported global health status/QoL per EORTC QLQ-C30
Up to 28 days
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Up to 5 years
Concentrations of REGN5458 in the serum over time
Duration of response (DOR) using the IMWG criteria
Effects of REGN5458 on HRQOL and patient-reported symptoms and functioning per EuroQoL-5 Dimension-3 Level Scale [EQ-5D-3L])
Effects of REGN5458 on HRQOL and patient-reported symptoms and functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Effects of REGN5458 on HRQOL and patient-reported symptoms and functioning per Quality of Life Questionnaire-Multiple Myeloma module 20 [QLQ-MY20])
Effects of REGN5458 on general health status per EQ-5D-3L
Effects of REGN5458 on patient-reported functions and symptoms per EORTC QLQ-C30
Effects of REGN5458 on patient-reported functions and symptoms per QLQ-MY20
Incidence and severity of AESIs with REGN5458
Incidence and severity of TEAEs with REGN5458
Incidence and severity of adverse events of special interest (AESI)
Incidence and severity of adverse events of special interest (AESIs)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence over time of anti-drug antibodies (ADAs) to REGN5458
Incidence over time of treatment-emergent anti-drug antibodies (ADAs) to REGN5458
ORR as measured using the IMWG criteria
Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria
Overall survival (OS)
Progression-free survival (PFS) as measured using the IMWG criteria
Rate of minimal residual disease (MRD) negative status using the IMWG criteria
Time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

1 Treatment Group

REGN5458
1 of 1
Experimental Treatment

291 Total Participants · 1 Treatment Group

Primary Treatment: REGN5458 · No Placebo Group · Phase 1 & 2

REGN5458
Drug
Experimental Group · 1 Intervention: REGN5458 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
543 Previous Clinical Trials
199,173 Total Patients Enrolled
3 Trials studying Multiple Myeloma
299 Patients Enrolled for Multiple Myeloma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
223 Previous Clinical Trials
87,964 Total Patients Enrolled
1 Trials studying Multiple Myeloma
256 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 1 or 2.
You have a confirmed diagnosis of active MM.
You have a disease that is refractory to treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.