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Corticosteroid

Linvoseltamab vs EPd for Multiple Myeloma (LINKER-MM3 Trial)

Phase 3

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximatively 5 years

Awards & highlights

LINKER-MM3 Trial Summary

This trial is researching an experimental drug, linvoseltamab, to see if it's a safe and effective treatment for multiple myeloma that has returned after 1-4 treatments. It will be compared to a standard regimen of 3 drugs. Outcomes studied include benefit, side effects, longevity, & pain relief.

Who is the study for?

This trial is for people with multiple myeloma that's come back or needs more treatment after 1-4 previous therapies. They must have measurable disease, be mostly active (ECOG ≤1), and have used lenalidomide and a proteasome inhibitor before. Their blood, liver, kidneys, heart, and bone marrow should work well enough to handle the treatments.Check my eligibility

What is being tested?

The study compares linvoseltamab (REGN5458) with a standard combo of cancer drugs: elotuzumab, pomalidomide & dexamethasone (EPd). Participants are split into two groups; one gets linvoseltamab while the other receives EPd. The goal is to see which group does better in terms of safety, effectiveness, side effects duration of benefit and overall survival.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal cells by mistake (autoimmunity), infusion-related reactions from receiving drugs through veins, fatigue from low energy levels, digestive issues like nausea or diarrhea and increased risk of infections.

LINKER-MM3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximatively 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximatively 5 years

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

Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants

Secondary outcome measures

Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants

Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies

Change in patient-reported QoL, per EORTC QLQ-C30 in all participants

+60 more

LINKER-MM3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LinvoseltamabExperimental Treatment1 Intervention

Randomization 1:1

Group II: Elotuzumab/Pomalidomide/Dexamethasone (EPd)Active Control3 Interventions

Randomization 1:1

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

622 Previous Clinical Trials

380,351 Total Patients Enrolled

9 Trials studying Multiple Myeloma

1,113 Patients Enrolled for Multiple Myeloma

Clinical Trials AdminstratorStudy DirectorRegeneron Pharmaceuticals

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

251,034 Total Patients Enrolled

6 Trials studying Multiple Myeloma

1,042 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

How many individuals are being included in the current research trial?

"Affirmative. According to clinicaltrials.gov, the trial which was first made available on September 18th 2023 is still actively recruiting for 286 patients at 7 different locations as of November 27th 2023."

Answered by AI

Are any participants currently joining this research project?

"Affirmative. According to the information available at clinicaltrials.gov, this medical trial is still open for recruitment and commenced on September 18th 2023 with a recent update posted on November 27th 2023. The study requires 286 participants from seven different sites."

Answered by AI

Could you elaborate on the potential risks associated with Linvoseltamab?

"Linvoseltamab has been found to be relatively safe, garnering a score of 3 due to available clinical research showing efficacy and multiple safety reviews."

Answered by AI

Can you inform me of the locations in North America where this medical experiment is underway?

"Currently, 7 sites are enrolling participants in this trial. These include Geelong, Stony Brook and Seoul with additional clinics located nearby. If you choose to participate, it may be useful to select a site close by as to lessen the burden of travel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

2023. "A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730036.