A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria — Up to 5 years
- Biochemical PFS per IMWG criteria — Up to 5 years
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 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 |
| 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 | Recruiting |
| Norfolk and Norwich University Hospital | Norwich | Norfolk | Recruiting |
| University Hospitals Leicester | Leicester | United Kingdom | Recruiting |
On this site
📄 Darzalex (daratumumab) drug profile →More Regeneron Pharmaceuticals trials in South Korea
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 South Korea