A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
NCT07393282 · Phase 3 · Phoenix, Arizona, United States
- Condition
- Multiple Myeloma
- Disease stage
- Stage I-IV
- Phase
- Phase 3
- Study type
- DRUG
- Intervention
- Linvoseltamab, Daratumumab
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Regeneron Pharmaceuticals
- Research institution
- Regeneron Pharmaceuticals
- Facility
- Mayo Clinic Phoenix, Mayo Clinic Building
- Research center
- Mayo Clinic Phoenix, Mayo Clinic Building
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)
Inclusion criteria
Key 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 leukoencephalopathy, or Central Nervous System (CNS) movement disorder 4. History of a seizure within the 12 months of randomization 5. Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol. NOTE: Other protocol defined inclusion/exclusion criteria apply
Primary outcomes
Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria; Biochemical PFS per IMWG criteria
Secondary outcomes
Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria; Time to death; Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria