A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
Regeneron Pharmaceuticals
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
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugLinvoseltamab
Administered per the protocol
- DrugDaratumumab
Administered per the protocol
Location
- Dana Farber / Harvard Cancer CenterBoston, Massachusetts