A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Official 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 Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 270 participants

Study Arms

• Linvoseltamab (EXPERIMENTAL)
• Daratumumab (ACTIVE_COMPARATOR)

Interventions

• DRUG: Linvoseltamab — Administered per the protocol
• DRUG: Daratumumab — Administered per the protocol

Primary Outcomes

• Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria (Up to 5 years)
• Biochemical PFS per IMWG criteria (Up to 5 years)

Secondary Outcomes

• Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria (Up to 3 years)
• Time to death (Up to 9 years)
• Achievement of Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria (Up to 3 years)
• Best Overall Response (BOR) per IMWG criteria (Up to 3 years)
• Achievement of MRD-negativity (Up to 3 years)

Eligibility Criteria

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 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

Contact Information

• Clinical Trials Administrator — CONTACT
  Phone: 844-734-6643
  Email: clinicaltrials@regeneron.com

Study Officials

• Clinical Trial Management — STUDY_DIRECTOR
  Regeneron Pharmaceuticals

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