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New drug linvoseltamab shows promise for Hard-to-Treat multiple myeloma

NCT ID NCT03761108

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called linvoseltamab in people with multiple myeloma that has returned or stopped responding to other treatments. The goal is to find the safest and most effective dose and to see if the drug can shrink or control the cancer. About 387 participants will be involved in this early-phase trial.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 387 people

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

Started

Jan 2019

Expected to finish

Jun 2033

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. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol. * Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment. * Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. * Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria: 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR 2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then: • Treatment with a CAR-T must have been associated with a response of PR or better, and • If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with linvoseltamab. Key Exclusion Criteria: 1\. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement 3. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) 4. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excluded and BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3. 5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment Note: Other protocol defined inclusion / exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence

As listed by the trial registrant

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

Multiple myeloma

How to take part

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

  1. The places running it

    26 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

  • Barbara Ann Karmanos Cancer Center

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48201, United States

  • C. S. Mott_University of Michigan

    ACTIVE_NOT_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Columbia University Medical Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Gunma University Hospital

    RECRUITING

    Maebashi, Gunma, 371-8511, Japan

  • Hospital Clinico Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalonia, 08041, Spain

  • Ibaraki Prefectural Central Hospital

    RECRUITING

    Kasama-shi, Ibaraki, 309-1793, Japan

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University_Michigan Street

    ACTIVE_NOT_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    COMPLETED

    Nagoya, Aichi-ken, 466-8650, Japan

  • Japanese Red Cross Medical Center

    COMPLETED

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Keio University Hospital

    RECRUITING

    Tokyo, 160-8582, Japan

  • Moffitt Cancer Center - McKinley Drive

    RECRUITING

    Tampa, Florida, 33612, United States

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Center Korea

    RECRUITING

    Goyang, 10408, South Korea

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Ohio State University James Cancer Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University (OHSU) Marquam Hill Campus

    RECRUITING

    Portland, Oregon, 97239, United States

  • Royal Marsden Hospital

    WITHDRAWN

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    ACTIVE_NOT_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saitama Medical University International Medical Center

    COMPLETED

    Hidaka, Saitama, 350-1298, Japan

  • Seoul National University Cancer Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

  • Sylvester Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33136, United States

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

    RECRUITING

    Seoul, 06591, South Korea

  • Tokushima Prefectural Central Hospital

    RECRUITING

    Tokushima, Tokushima, 770-8539, Japan

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    COMPLETED

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Universitary Hospital La Princesa

    RECRUITING

    Madrid, Salamanca, 28006, Spain

  • Universitatsklinikum Essen

    COMPLETED

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitatsklinikum Wurzburg

    COMPLETED

    Würzburg, 6 97080, Germany

  • University Hospital Kyoto Prefectural Univ of Medicine

    RECRUITING

    Kyoto, Kyoto, 602-8566, Japan

  • University of Texas MD Anderson Clinic

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Yonsei University College of Medicine, Severance Hospital

    RECRUITING

    Seoul, 3722, South Korea

  • ZNA Psychiatrisch Ziekenhuis Stuivenberg

    RECRUITING

    Antwerp, 2060, Belgium

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