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Comparing linvoseltamab to a combination of three other cancer drugs for relapsed/refractory multiple myeloma

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)

Phase 3 Interventional Regeneron Pharmaceuticals · NCT05730036

This study is testing if a new drug called linvoseltamab works better than a standard combination of three other cancer drugs for adults with relapsed or refractory multiple myeloma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment410 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionselotuzumab, linvoseltamab
Locations159 sites (Los Angeles, California and 158 other locations)
Trial IDNCT05730036 on ClinicalTrials.gov

What this trial studies

This clinical trial is investigating the effectiveness and safety of linvoseltamab, an experimental drug, in comparison to a combination of elotuzumab, pomalidomide, and dexamethasone for adults with relapsed or refractory multiple myeloma. Participants must have previously undergone one to four lines of treatment and show disease progression. The study aims to determine if linvoseltamab can provide better outcomes than the standard combination therapy. The trial will assess tumor shrinkage and overall response rates among participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older who have relapsed or refractory multiple myeloma and have received between one to four prior lines of therapy.

Not a fit: Patients who have not received prior anti-neoplastic therapies or those with ECOG performance status greater than 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Previous studies have shown promising results for linvoseltamab in treating advanced multiple myeloma, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
2. 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.
3. 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.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
6. Life expectancy of at least 6 months

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
5. 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.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
7. 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).
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
9. 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

Where this trial is running

Los Angeles, California and 158 other locations

+109 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed Refractory Multiple MyelomaBCMA X CD3 Bispecific Monoclonal AntibodyCD38 antibodyProteasome inhibitorLenalidomide
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.