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REGN5458 for Multiple Myeloma

Phase-Based Progress Estimates

Effectiveness

Safety

Multiple Myeloma+1 More

REGN5458 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

WVT078

ION251

REGN7075

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

WVT078

ION251

REGN7075

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 - 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.

References