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Looking for participantsPhase3

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT07222761

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), Carfilzomib (drug), Daratumumab (drug), Dexamethasone (drug)
How long the study runs
Study runs about 103 months (dates as stated)
About the drug or intervention
Linvoseltamab — drug: Administered per the protocol · Carfilzomib — drug: Administered per the protocol · Daratumumab — drug: Administered per the protocol · Dexamethasone — drug: Administered per the protocol · Pomalidomide — drug: Administered per the protocol · Bortezomib — drug: Administered per the protocol
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
915
Started
2026-01-02
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for relapsed and/or refractory multiple myeloma (rrmm)
  • • Phase3 - 915 participants
  • • This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies

Who can take part?

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

Where?

  • • Aberdeen - Aberdeen Royal Infirmary
  • • Truro - Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
  • • Plymouth - University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
  • • Norwich - Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
  • • +2 more UK sites

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

About This Trial

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies. The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Relapsed and/or Refractory Multiple Myeloma (RRMM)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

Biomarkers mentioned

CD38

What the study is looking for

  • ✓activity scale (ECOG) performance status score ≤2
  • ✓Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Who cannot take part

  • ✗Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
  • ✗History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
  • ✗NOTE: Other protocol defined inclusion/exclusion criteria apply
See the full criteria
Key Inclusion Criteria: 1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy Key Exclusion Criteria: 1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded 2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement 4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder NOTE: Other protocol defined inclusion/exclusion criteria apply

Where Is This Study? (6 UK sites)

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Royal Cornwall Hospital National Health Service (NHS) Foundation Trust

Truro TR1 3LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology

Plymouth PL6 8DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

University Hospitals Birmingham NHS Trust, Center for Clinical

Birmingham B15 2GW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Ninewells Hospital and Medical School

Dundee DD1 9SY, United Kingdom

Recruiting

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