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Multiple MyelomaPhase 1/2LINKER-MM4NCT05828511

A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

A Phase 1/2 study testing Linvoseltamab in people with Multiple Myeloma, run by Regeneron Pharmaceuticals at 32 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Linvoseltamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
32 sitesin 3 countries
Study dates
19 Dec 2023to 2 Nov 2035
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
  • Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
  • No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
  • Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
  • Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.

Who cannot join

  • Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
  • Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
  • Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
  • Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

32 sites in 3 countries.

32 sites in 3 countries

United States13 sites

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Colorado Blood Cancer Institute/SCRI

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Health System (DUHS)

    Durham, North Carolina, 27705

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Perlmutter Cancer Center

    New York, New York, 10016

  • Columbia University _ New York Presbyterian

    New York, New York, 10032

  • UC Irvine Health

    Orange, California, 92868

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

Other trials in United States

Spain11 sites

  • Hospital General Universitario Doctor Balmis Alicante

    Alicante, Valencia, 03010

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catala dOncologia (ICO Hospitalet)

    Barcelona, 08908

  • Universitary Hospital La Princesa

    Madrid, 28006

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France8 sites

  • Hopital Prive d'Antony

    Antony, Île-de-France Region, 92160

  • CHU De Lille

    Lille, 59000

  • Centre Hospitalier Universitaire (CHU) Montpellier

    Montpellier, 342950

  • Hopital Saint Louis

    Paris, 75010

  • University Hospitals Pitie Salpetriere - Charles Foix

    Paris, 75651

  • Hopital Necker

    Paris, Île-de-France Region, 75015

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, Vienne, 86021

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94800

Other trials in France

About this study

Official title: Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible).

The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM.

Read more

This study consists of 2 phases:

  • In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2.
  • In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug.
  • In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM.

The study is looking at several research questions, including:

  • What side effects may happen from taking linvoseltamab?
  • What the right dosing regimen is for linvoseltamab?
  • How many participants treated with linvoseltamab have improvement of their disease and for how long?
  • The effects of linvoseltamab study treatment before and after transplant
  • How much linvoseltamab is in the blood at different times?
  • Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).
Being tested
Linvoseltamab
Keywords
Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplantation (ASCT), Cluster of Differentiation 3 (CD3), BCMA, High Dose chemoTherapy (HDT), International Myeloma Working Group (IMWG)
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called REGN5458, Lynozyfic™

    Linvoseltamab will be administered by intravenous (IV) infusion

Study groups in NCT05828511
Study groupRoleWhat they receive
Phase 1 cohortsExperimentalLinvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.
Receives: Drug: Linvoseltamab
Phase 2 - transplant ineligible cohortExperimentalTransplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.
Receives: Drug: Linvoseltamab
Phase 2 - transplant eligible cohortExperimentalTransplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol
Receives: Drug: Linvoseltamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Phase 1

    Measured: End of the Observation period; up to day 28

  2. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  3. Severity of TEAEs

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  4. Incidence of Adverse Events of Special Interest (AESIs)

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  5. Severity of AESIs

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  6. Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria

    Phase 2

    Measured: Up to 5 years

  7. Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy

    Phase 2 Transplant-eligible cohort

    Measured: Up to 5 years

  8. Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy

    Phase 2 Transplant-eligible cohort

    Measured: Up to 5 years

  9. Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II

    Phase 2 Transplant-ineligible cohort

    Measured: Up to 5 years

  10. Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II

    Phase 2 Transplant ineligible cohort

    Measured: Up to 5 years

Secondary outcomes (28)

  1. Concentrations of Linvoseltamab in serum

    Phases 1 and 2

    Measured: Post-Last Linvoseltamab Dose, up to 12 weeks

  2. Concentrations of total soluble B-Cell Maturation Antigen (BCMA)

    Phases 1 and 2

    Measured: Post-Last Linvoseltamab Dose, up to 12 weeks

  3. Incidence of Anti-Drug Antibodies (ADAs) to Linvoseltamab

    Phases 1 and 2

    Measured: Post-Last Linvoseltamab Dose, up to 30 days

  4. Magnitude of ADAs to Linvoseltamab

    Phases 1 and 2

    Measured: Post-Last Linvoseltamab Dose, up to 30 days

  5. Objective Response Rate (ORR) measured using the IMWG criteria

    Phase 1

    Measured: Up to 5 years

  6. Duration Of Response (DOR) measured using the IMWG criteria

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  7. Progression-Free Survival (PFS) measured using the IMWG criteria

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  8. Proportion of participants achieving MRD-negative status (at 10^-5) in participants with NDMM measured using the IMWG criteria

    Phase 1

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  9. Incidence of TEAEs

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  10. Severity of TEAEs

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  11. Incidence of AESIs

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  12. Severity of AESIs

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  13. ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician

    Phase 2

    Measured: Up to 5 years

  14. MRD-negative status of participants deemed transplant-eligible and transplant-ineligible by the treating physician

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  15. DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  16. PFS of participants deemed transplant-eligible and transplant-ineligible by the treating physician

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  17. Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  18. Time To Response (TTR) as measured using the IMWG criteria

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  19. ORR by risk levels

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  20. MRD-negative status by risk levels

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  21. DOR by risk levels

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  22. TTR by risk levels

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  23. PFS by risk levels

    Phase 2

    Measured: Post-Last Linvoseltamab Dose, up to 90 days

  24. Incidence of MRD-negative status

    Phase 2

    Measured: Up to 5 years

  25. Cluster of Differentiation 34+ (CD34+) stem cell yield

    Phase 2 Transplant-eligible cohort

    Measured: At cycle 4 of induction (each cycle is 28 days long)

  26. Time to neutrophil engraftment

    Phase 2 Transplant-eligible cohort

    Measured: Up to 100 days post-transplant

  27. Time to platelet engraftment

    Phase 2 Transplant-eligible cohort

    Measured: Up to 100 days post-transplant

  28. PFS after ASCT followed by 3 cycles of linvoseltamab

    Phase 2 Transplant-eligible cohort

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start19 Dec 2023
  3. Primary completion2 Nov 2035 (estimated)
  4. Study completion2 Nov 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Note: Phase 1 part B will be randomized 1:1. All other participants will be non-randomized.
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828511
Sponsor's protocol ID
R5458-ONC-2158
Other IDs
2022-500800-24-00
Acronym
LINKER-MM4
Status last verified
Nov 2026
First submitted
12 Apr 2023
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Linvoseltamab in people with Multiple Myeloma, run by Regeneron Pharmaceuticals at 32 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicities (DLTs) (time frame: End of the Observation period; up to day 28). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05828511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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