Recruiting

LINKER-MM5Linvoseltamab and Carfilzomib for Relapsed/Refractory Multiple Myeloma

What is being tested

Linvoseltamab

+ Carfilzomib

+ Daratumumab

Drug

Who is being recruted

Over 18 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorRegeneron Pharmaceuticals

Study ContactClinical Trials Administrator

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 2, 2026

Actual date on which the first participant was enrolled.

This research is focused on testing a new treatment approach for patients with Multiple Myeloma, a type of blood cancer that has returned or not responded to previous treatments. The study is investigating the effectiveness of a drug called linvoseltamab, both on its own and when combined with another medication, carfilzomib. These new treatment options are compared to the usual treatments that patients typically receive after having gone through one to three prior therapies. The goal is to find out if linvoseltamab can offer better results, such as more effective disease control and prolonged survival, which would be a significant advancement in managing this condition. Participants in this study will receive either the new treatment regimen or one of the standard care treatments, which will be administered as determined by the study protocol. Researchers will closely monitor participants to evaluate the safety and effectiveness of linvoseltamab by checking for any side effects, measuring the levels of the drug in the blood over time, and observing whether patients develop antibodies against the drug, which could reduce its effectiveness. The study aims to understand not only the benefits but also the potential risks associated with the new treatment options, ensuring a comprehensive assessment of their impact on patient care.

Official TitleAn Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

NCT07222761

Principal SponsorRegeneron Pharmaceuticals

Study ContactClinical Trials Administrator

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

915 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

Eastern Cooperative Oncology Group (ECOG) performance status score <= 2

1 exclusion criteria prevent from participating

Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Recruiting

Gold Coast Hospital and Health Service

Southport, AustraliaOpen Gold Coast Hospital and Health Service in Google Maps

Recruiting

Seoul National University Hospital

Seoul, South Korea

Recruiting

Severance Hospital; Division of Hematology

Seoul, South Korea

Recruiting

Samsung Medical Center

Seoul, South Korea

Recruiting

9 Study Centers