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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

Must not have

Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA)

Patients with known MM brain lesions or meningeal involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's pumping ability is less than 40%.

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I have brain lesions or meningeal involvement due to multiple myeloma.

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I have previously received BCMA-targeted immunotherapy.

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I have been diagnosed with a rare blood disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met