NCT07393282From ClinicalTrials.govRecruiting

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

High Risk Smoldering Multiple Myeloma (HR-SMM)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Regeneron Pharmaceuticals
Enrolment target: 270
Started: 21 May 2026
Main results due: 27 July 2033
Study sites: 19
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol
2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma
3. History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
4. History of a seizure within the 12 months of randomization
5. 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

What this study is about

In the sponsor’s own words, from the registry.

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)

Study sites(19)

Mayo Clinic Phoenix, Mayo Clinic Building
Phoenix, Arizona, United States
Recruiting
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, United States
Recruiting
Barbara Ann Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Ohio State University
Columbus, Ohio, United States
Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Recruiting
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
Recruiting
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, Japan
Recruiting
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Recruiting
National Hospital Organization Matsumoto Medical Center
Matsumoto-shi, Japan
Recruiting
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Recruiting
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Recruiting
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Recruiting
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Recruiting
University Hospitals Leicester
Leicester, United Kingdom
Recruiting

Showing 19 of 19 sites. 19 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07393282. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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