NCT06932562

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: European Myeloma Network B.V. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Linvoseltamab	Administered per the protocol
DRUG	Daratumumab	Administered per the protocol
DRUG	Lenalidomide	Administered per the protocol
DRUG	Dexamethasone	Administered per the protocol

Timeline

• Start date: 2025-12-23
• Primary completion: 2036-12-01
• Completion: 2036-12-01
• First posted: 2025-04-17
• Last updated: 2026-03-25

Locations

59 sites across 18 countries: Australia, Austria, Croatia, Czechia, Denmark, Estonia, Finland, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study