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NCT07393282RecruitingPhase 3

A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma. The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM. 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)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
270 (estimated)
First submitted
29 Jan 2026
Start date
21 May 2026
Primary completion date
27 Jul 2033
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT07393282
EU CT number
2025-523252-31-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 270
  • From 21 May 2026 to the primary completion date, 27 Jul 2033
  • 74 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.
    • NOTE: Other protocol defined inclusion/exclusion criteria apply

Other illness

  • History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
  • History of a seizure within the 12 months of randomization

Other

  • Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol
  • Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma

Who the study is looking for

  • Eastern Cooperative Oncology Group performance status score ≤1
  • SMM diagnosis per IMWG criteria as defined in the protocol
  • Meets HR-SMM criteria by 1 of the risk models as defined in the protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (74)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Center Hamburg-Eppendorf
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HamburgGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyNot yet recruiting
Klinikum Oldenburg Aor
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OldenburgGermanyNot yet recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainNot yet recruiting
Institut Catala d'Oncologia
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BadalonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainNot yet recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainNot yet recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainNot yet recruiting
Hospital General Universitario Morales Meseguer
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MurciaSpainNot yet recruiting
Hospital Son Llatzer
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PalmaSpainNot yet recruiting
Clínica Universidad de navarra
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PamplonaSpainNot yet recruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainNot yet recruiting
Hospital Universitari Mutua Terrassa
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TerrassaSpainNot yet recruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainNot yet recruiting
Hospital Universitario Araba
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VitoriaSpainNot yet recruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceNot yet recruiting
Centre Hospitalier De Cannes Simone Veil
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Cannes CedexFranceNot yet recruiting
Groupement Des Hopitaux De L'Institut Catholique De Lille
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Lille CedexFranceNot yet recruiting
Centre Leon Berard
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LyonFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceNot yet recruiting
Centre Hospitalier Universitaire De Bordeaux
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Pessac CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceNot yet recruiting
Centre Henri Becquerel
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Rouen CedexFranceNot yet recruiting
Institut Curie
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Saint-CloudFranceNot yet recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceNot yet recruiting
Institut Gustave Roussy
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VillejuifFranceNot yet recruiting
University Hospitals Leicester
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LeicesterUnited KingdomRecruiting
Saint Bartholomew's Hospital
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LondonUnited KingdomRecruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
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LondonUnited KingdomRecruiting
Norfolk and Norwich University Hospital
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NorwichUnited KingdomRecruiting
Royal Cornwall Hospital
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TruroUnited KingdomRecruiting
Evangelismos S A
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AthensGreeceNot yet recruiting
General Hospital of Athens - Alexandra
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AthensGreeceNot yet recruiting
Olympion General Clinic Patras P.C.
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PatrasGreeceNot yet recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceNot yet recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
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MilanItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
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VareseItalyNot yet recruiting
Yamanashi Prefectural Central Hospital
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KofuJapanRecruiting
National Hospital Organization Matsumoto Medical Center
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Matsumoto-shiJapanRecruiting
Nagoya City University Hospital
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NagoyaJapanRecruiting
National Hospital Organization Okayama Medical Center
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OkayamaJapanRecruiting
Tokushima Prefectural Central Hospital
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TokushimaJapanRecruiting
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
The Catholic University of Korea St Vincents Hospital
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SuwonSouth KoreaRecruiting
Oslo Universitetssykehus HF
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OsloNorwayNot yet recruiting
Pratia S.A.
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CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Emory University/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Dana-Farber Harvard Cancer Center
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BostonUnited StatesRecruiting
Ohio State University
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ColumbusUnited StatesRecruiting
Barbara Ann Karmanos Cancer Institute - Detroit
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DetroitUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Mayo Clinic Phoenix, Mayo Clinic Building
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PhoenixUnited StatesRecruiting
Mayo Clinic
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RochesterUnited StatesRecruiting
Washington University School of Medicine in St. Louis
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St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.