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Looking for participantsPhase3

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

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT05730036

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Linvoseltamab (drug), Elotuzumab (drug), Pomalidomide (drug), Dexamethasone (drug)
How long the study runs
Study runs about 115 months (dates as stated)
About the drug or intervention
Linvoseltamab — drug: REGN5458 will be administered by intravenous (IV) infusion · Elotuzumab — drug: Elotuzumab will be administered by IV infusion · Pomalidomide — drug: Pomalidomide capsules will be administered by mouth (PO) · Dexamethasone — drug: Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
410
Started
2023-09-18
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for relapsed refractory multiple myeloma (rrmm)
  • • Phase3 - 410 participants
  • • This study is researching an experimental drug called linvoseltamab, also called REGN5458

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with relapsed refractory multiple myeloma (rrmm)

Where?

  • • Cambridge - Addenbrooke's Hospital
  • • Edinburgh - Western General Hospital
  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • London - Barts Health NHS Trust
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Relapsed Refractory Multiple Myeloma (RRMM)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 2 or better

Biomarkers mentioned

CD38

Treatment history

Treatments you must have had:

  • ✓ of antimyeloma therapy must be lenalidomide refract
  • ✓ previously received a CD38 antibody

What the study is looking for

  • ✓Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
  • ✓activity scale (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms...
  • ✓Patients must have cancer that can be measured on scans for response assessment as per the 2016 IMWG response assessment criteria, as...
  • ✓healthy blood and liver function within 7 days of randomization, as well as adequate kidney and...
  • ✓expected to live at least 6 $2

Who cannot take part

  • ✗Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy,...
  • ✗Prior treatment with elotuzumab and/or pomalidomide
  • ✗Participants with known MM brain lesions or meningeal involvement
  • ✗Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of...
  • ✗Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates...
See the full 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 Is This Study? (8 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Barts Health NHS Trust

London EC1A 7BE, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Guy's & St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

Royal Marsden Hospital

London SW7 3RP, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Hammersmith Hospital

London W12 0HS, United Kingdom

ACTIVE_NOT_RECRUITING

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10