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Monoclonal Antibodies

Linvoseltamab for Multiple Myeloma (LINKER-MGUS1 Trial)

Phase 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

HR-MGUS or NHR-SMM as defined in the protocol

Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new drug, linvoseltamab, in patients with high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non high-risk sm

Who is the study for?

Adults with high-risk monoclonal gammopathy (HR-MGUS) or non-high-risk smoldering multiple myeloma (NHR-SMM) can join this study. They should be relatively healthy, able to perform daily activities with ease (ECOG ≤1), and have good blood and liver function. Their kidneys must also work well enough to filter waste from the blood.

What is being tested?

The trial is testing Linvoseltamab's ability to eliminate abnormal plasma cells in patients with HR-MGUS or NHR-SMM. It starts with increasing doses of Linvoseltamab, followed by a full dose. The first part checks safety at different doses; the second part compares dosing regimens for effectiveness and side effects.

What are the potential side effects?

Possible side effects include reactions related to how the body tolerates Linvoseltamab, which will be closely monitored during initial treatment phases. Other concerns are whether the drug might cause immune responses that could reduce its effectiveness or lead to additional side effects.

Eligibility Criteria

Inclusion Criteria

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

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My condition is either high-risk MGUS or smoldering myeloma.

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I am fully active and can carry on all pre-disease activities without restriction.

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My kidney function, measured by GFR, is adequate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.5 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

Achievement of complete response (CR) as determined by the investigator

Frequency of adverse events of special interest (AESI) during the safety observation period

Frequency of treatment-emergent adverse event (TEAEs) during the safety observation period

+1 more

Secondary study objectives

Frequency of TEAEs

Frequency of laboratory abnormalities

Severity of TEAEs

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Safety Run-In (Part 1)Experimental Treatment1 Intervention

Sequential groups of participants will be enrolled to assess the initial safety and tolerability of the step-up regimen leading up to the start of different full doses of linvoseltamab.

Group II: Expansion (Part 2) - Dose regimen 4Experimental Treatment1 Intervention

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

Group III: Expansion (Part 2) - Dose regimen 3Experimental Treatment1 Intervention

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

Group IV: Expansion (Part 2) - Dose regimen 2Experimental Treatment1 Intervention

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

Group V: Expansion (Part 2) - Dose regimen 1Experimental Treatment1 Intervention

Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

0 / 3Eligibility criteria met