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Taking peoplePhase 3

Compares linvoseltamab with EPd in relapsed or refractory multiple myeloma

Tests linvoseltamab against EPd in adults with returned multiple myeloma.

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Hamburg, Lübeck, and Tuebingen, GermanySee the 3 sitesAlso in 17 other countries, 147 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
410 people, planned
Started
18 Sept 2023
Expected to end
19 Apr 2033
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Linvoseltamab
  • Elotuzumab
  • Pomalidomide
  • Dexamethasone
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose multiple myeloma has come back or stopped responding after 1 to 4 earlier treatments. It compares linvoseltamab with elotuzumab, pomalidomide and dexamethasone (EPd).

Age
18 years or older (or the legal adult age in the country).
Sex
All sexes can join.
Disease stage
Relapsed or refractory multiple myeloma with measurable disease. The disease must have progressed on or after the last treatment.
Earlier treatment
Must have had 1 to 4 earlier myeloma treatments, including lenalidomide and a proteasome inhibitor. People with only 1 earlier treatment must be lenalidomide refractory. In Israel, a CD38 antibody is also needed. In the EU and the UK, 2 to 4 earlier treatments including a CD38 antibody are needed. Earlier elotuzumab, pomalidomide or BCMA-directed immunotherapy is not allowed.

Main reasons for not taking part

  • Plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia or POEMS syndrome
  • Prior treatment with elotuzumab and/or pomalidomide, or with BCMA-directed immunotherapy (BCMA antibody-drug conjugates are allowed)
  • Myeloma in the brain or the membranes around it
  • Recent stem cell transplant (allogeneic within 6 months, autologous within 12 weeks)
  • Uncontrolled infection, including HIV, hepatitis B or hepatitis C

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Age 18 years or older (or legal adult age in the country) at the time of the screening visit
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor
  • Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol; Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody
  • Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
  • Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
  • Life expectancy of at least 6 months

Who cannot take part

  • Prior treatment with elotuzumab and/or pomalidomide
  • Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
  • History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable
  • Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed
  • Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
  • Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism)
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction <40%; NOTE: Other protocol defined inclusion/exclusion criteria apply
  • Participants with known MM brain lesions or meningeal involvement

Where in Germany

Also in 17 other countries, 147 sites

  • University Medical Center Hamburg-EppendorfHamburg, GermanyNo longer taking part
  • University Medical Centre Schleswig-HolsteinLübeck, GermanyNo longer taking part
  • Universitaetsklinikum Tuebingen AöRTuebingen, GermanyNo longer taking part

About the trial

What the trial wants to find out

This study is researching an experimental drug called linvoseltamab, also called REGN5458.

Read full original descriptionShow less

Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).

This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.

This study is looking at several other research questions, including:

* How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd

The 2 groups in the trial

  • LinvoseltamabTreatment being tested

    Randomization 1:1

  • Elotuzumab/Pomalidomide/Dexamethasone (EPd)Existing treatment, for comparison

    Randomization 1:1

    Treatment: Elotuzumab, Pomalidomide, and Dexamethasone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
Plain-language title
Compares linvoseltamab with EPd in relapsed or refractory multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026