🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07393282
Recruiting Phase 3

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

NCT07393282 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2026-05-21
Last updated
2026-09-15

Condition(s) studied

High Risk Smoldering Multiple Myeloma (HR-SMM)

Investigational drug(s) / intervention(s)

LinvoseltamabDaratumumab

Linvoseltamab: Administered per the protocol

Daratumumab: Administered per the protocol

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (14)

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

On this site

📄 Darzalex (daratumumab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07393282 on ClinicalTrials.gov ↗ ← All trials in the USA