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A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Study acronym: LINKER-MM5
StatusRecruiting
PhasePhase 3
Started2026-01-02
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 24 → 28 locations
Trial sites expanded: 20 → 24 locations
2026-06-30
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 16 → 20 locations
2026-05-29
minor
Study Status v7
Primary completion date2029-06-15→2029-05-21
Completion date2034-09-17→2034-08-23
2026-05-07
minor
Study Status, Contacts/Locations v6
Study sites14→16
2026-04-22
minor
Study Status, Contacts/Locations v5
Study sites13→14
2026-04-07
minor
Study Status, Contacts/Locations v4
Trial sites expanded: 9 → 13 locations
2026-03-18
minor
Study Status, Contacts/Locations v3
Study sites3→9
2026-02-23
minor
Study Status, Contacts/Locations v2
Study sites2→3
2026-01-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-06-18→2029-06-15
Completion date2034-09-20→2034-09-17
Start dateestimated 2026-01-29→confirmed 2026-01-02
Study sites0→2
2025-10-28
minor
Original filing
148 trials monitored
See 16 trials at risk
1,228 trials monitored
See 75 trials at risk
This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies. The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options. 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 NCT07222761
Lead Sponsor Regeneron Pharmaceuticals
Conditions Relapsed and/or Refractory Multiple Myeloma (RRMM)
Enrollment 915 participants
Start Date 2026-01-02
Primary Completion 2029-05-21 (estimated)
Study Completion 2034-08-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-29