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Monoclonal Antibodies

REGN5458 for Multiple Myeloma (LINKER-MM1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol

Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

LINKER-MM1 Trial 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.

Who is the study for?

This trial is for adults with Multiple Myeloma who've tried at least three prior treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody but haven't seen improvement. They should be in relatively good health otherwise (ECOG ≤ 1). People can't join if they have certain other blood disorders or brain involvement of myeloma, severe heart issues, previous BCMA-targeted therapy except antibody-drug conjugates, or recent stem cell transplants.Check my eligibility

What is being tested?

The study tests REGN5458 as a solo treatment to see how safe it is and what dose works best (Phase 1), then checks its effectiveness against Multiple Myeloma that's resisted standard treatments (Phase 2). Researchers will also look into how the body processes the drug and any potential impact on quality of life.See study design

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea. The full range of side effects isn't known yet since this is part of what the trial aims to discover.

LINKER-MM1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My myeloma can be measured for treatment response.

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I have been diagnosed with active Multiple Myeloma.

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I have multiple myeloma and no remaining treatment options that could significantly help me.

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My cancer returned after a specific cell therapy targeting BCMA.

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I am fully active or can carry out light work.

LINKER-MM1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concentrations of REGN5458 in serum over time

Incidence and severity of adverse events of special interest (AESI)

Incidence and severity of cytokine release syndrome (CRS) with REGN5458

+4 more

Secondary outcome measures

Change in patient-reported global health status/QoL per EORTC QLQ-C30

Concentrations of REGN5458 in the serum over time

DOR as determined by an investigator, measured using the International Myeloma Working Group (IMWG) criteria

+20 more

LINKER-MM1 Trial Design

4Treatment groups

Experimental Treatment

Group I: Linvoseltamab - Phase 2 - Cohort 3Experimental Treatment1 Intervention

Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV dose of REGN5458 monotherapy. Note: Cohort 3 is not applicable for US.

Group II: Linvoseltamab - Phase 2 - Cohort 2Experimental Treatment1 Intervention

High Dose of REGN5458/linvoseltamab IV monotherapy.

Group III: Linvoseltamab - Phase 2 - Cohort 1Experimental Treatment1 Intervention

Low Dose of REGN5458/linvoseltamab IV monotherapy.

Group IV: Linvoseltamab - Phase 1Experimental Treatment1 Intervention

Phase 1 has two parts. Part 1, consists of REGN5458/linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration. Note: subcutaneous (SC) administration is not applicable for US.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

621 Previous Clinical Trials

380,218 Total Patients Enrolled

9 Trials studying Multiple Myeloma

1,106 Patients Enrolled for Multiple Myeloma

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

251,027 Total Patients Enrolled

6 Trials studying Multiple Myeloma

1,035 Patients Enrolled for Multiple Myeloma

Media Library

REGN5458 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03761108 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Linvoseltamab - Phase 1, Linvoseltamab - Phase 2 - Cohort 1, Linvoseltamab - Phase 2 - Cohort 2, Linvoseltamab - Phase 2 - Cohort 3

Multiple Myeloma Clinical Trial 2023: REGN5458 Highlights & Side Effects. Trial Name: NCT03761108 — Phase 1 & 2

REGN5458 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03761108 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participant enrollment for this clinical experiment?

"To satisfy the trial's requirements, 291 participants who meet its eligibility criteria must volunteer. Those from Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Miami, Florida or University of Miami Hospital/Sylvester Comprehensive in Indianapolis can also take part."

Answered by AI

What aims are being sought in this clinical experiment?

"The principal aim of this clinical experiment, spanning up to 5 years, is to monitor the frequency of dose-limiting toxicities (DLTs) following initial administration and throughout DLT observation. Secondary objectives include observing changes in patient reported global health status/quality of life according to EORTC QLQ-C30 for Phase 2; measuring incidence over time for treatment-emergent anti-drug antibodies (ADAs) towards REGN5458 during Phases 1 &2; and recording Duration Of Response using IMWG criteria from Phases 1 & 2."

Answered by AI

How many venues are participants accessing this research project?

"The current medical trial is recruiting from 25 different sites located in major cities such as Miami, Indianapolis and Ann Arbor. Patients are encouraged to choose the site closest to them for convenience if they decide to participate."

Answered by AI

Is the recruitment phase of this trial ongoing?

"Hosted on clinicaltrials.gov, this medical trial is still seeking participants; the study was first made available in January of 2019 and its details were most recently amended at the end of August 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

2019. "Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03761108.

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