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

Study acronym: LINKER-SMM2
StatusRecruiting
PhasePhase 3
Started2026-05-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Trial sites expanded: 14 → 19 locations
2026-08-17
Study Status, Contacts/Locations v5
Trial sites expanded: 3 → 14 locations
Study sites3 entries, revised
Barbara Ann Karmanos Cancer Institute - Detroit
2026-08-06
Study Status, Contacts/Locations v4
Study sites2→3
2026-07-07
Study Status, Contacts/Locations v3
Study sites1→2
2026-06-08
Study Status, Outcome Measures, Contacts/Locations v2
Recruitment opened
Primary completion date2033-07-22→2033-07-27
Completion date2033-07-22→2033-07-27
Start dateestimated 2026-03-25→confirmed 2026-05-21
Study sites0→1
Secondary endpoints24 entries, revised
Achievement of Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria
2026-03-12
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+23 characters
[...] Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder History o [...]
Secondary endpoints30 to 24 entries
Second PFS (PFS2) Time to Partial Response or better (≥PR) per IMWG criteria Time to Very Good Partial Response or better (≥VGPR) per IMWG criteria Time to ≥CR per IMWG criteria Time To Progression (TTP) per IMWG criteria Time to date of initiation of first-line MM therapy Change from baseline score in European Organization for Research and Treatment of Canc [...] C QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) scalesscale Change from baseline score in EORTC QLQ-C30 physical scalesfunctioning scale Change from baseline score in EORTC QLQ-C30 role scalesfunctioning scale Change from baseli [...] [...]
2026-02-05
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
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)
Trial Details
NCT Number NCT07393282
Lead Sponsor Regeneron Pharmaceuticals
Conditions High Risk Smoldering Multiple Myeloma (HR-SMM)
Enrollment 270 participants
Start Date 2026-05-21
Primary Completion 2033-07-27 (estimated)
Study Completion 2033-07-27 (estimated)
Updated on ClinicalTrials.gov 2026-09-25