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
- Diseases
- Multiple myeloma
- 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
Sites (74)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| Klinikum Oldenburg Aor Coordinator of this site? Confirm its status | Oldenburg | Germany | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Not yet recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Hospital General Universitario Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Not yet recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Not yet recruiting |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Not yet recruiting |
| Centre Hospitalier De Cannes Simone Veil Coordinator of this site? Confirm its status | Cannes Cedex | France | Not yet recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Pessac Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen Cedex | France | Not yet recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| University Hospitals Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Saint Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
| Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Olympion General Clinic Patras P.C. Coordinator of this site? Confirm its status | Patras | Greece | Not yet recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Not yet recruiting |
| Yamanashi Prefectural Central Hospital Coordinator of this site? Confirm its status | Kofu | Japan | Recruiting |
| National Hospital Organization Matsumoto Medical Center Coordinator of this site? Confirm its status | Matsumoto-shi | Japan | Recruiting |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Tokushima Prefectural Central Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul St. Mary's Hospital, The Catholic University of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St Vincents Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Dana-Farber Harvard Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Barbara Ann Karmanos Cancer Institute - Detroit Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mayo Clinic Phoenix, Mayo Clinic Building Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Washington University School of Medicine in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.