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New hope for Hard-to-Treat myeloma: phase 3 trial launches

NCT ID NCT07222761

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This study tests a new drug, linvoseltamab, alone or with another drug called carfilzomib, against standard treatments for people with multiple myeloma that has returned or not responded to prior therapy. About 915 participants who have had 1 to 3 prior treatments will be enrolled. The goal is to see if these new options can improve response and extend life while monitoring side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 915 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy Key Exclusion Criteria: 1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded 2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement 4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder NOTE: Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed and/or refractory multiple myeloma (RRMM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    RECRUITING

    Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

  • Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, Jeollanam-do, 58128, South Korea

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Gold Coast Hospital and Health Service

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Kaohsiung Medical University Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Mater Misericordiae Ltd

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Ninewells Hospital and Medical School

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust

    RECRUITING

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • OhioHealth

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Royal Cornwall Hospital National Health Service (NHS) Foundation Trust

    RECRUITING

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Royal Perth Hospital

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    RECRUITING

    Seoul, 06591, South Korea

  • Severance Hospital; Division of Hematology

    RECRUITING

    Seoul, 03722, South Korea

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Ulsan University Hospital

    RECRUITING

    Ulsan, 44033, South Korea

  • University Hospitals Birmingham NHS Trust, Center for Clinical

    RECRUITING

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology

    RECRUITING

    Plymouth, Devon, PL6 8DH, United Kingdom

  • University of Texas Health Science Center, Houston

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.