Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

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

NCT ID: NCT07393282Sponsor: Regeneron PharmaceuticalsLast updated: 2026-06-10

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)

Arms & interventions

  • DrugLinvoseltamab

    Administered per the protocol

  • DrugDaratumumab

    Administered per the protocol

Outcome measures

Primary

  • Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 5 years

  • Biochemical PFS per IMWG criteria

    Time frame: Up to 5 years

Secondary

  • Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria

    Time frame: Up to 3 years

  • Time to death

    Time frame: Up to 9 years

  • Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria

    Time frame: Up to 3 years

  • Best Overall Response (BOR) per IMWG criteria

    Time frame: Up to 3 years

  • Achievement of MRD-negativity

    Time frame: Up to 3 years

  • Sustained MRD-negativity

    Time frame: Up to 3 years

  • Duration of MRD-negative CR

    Time frame: Up to 3 years

  • Duration Of Response (DOR) per IMWG criteria

    Time frame: Up to 5 years

  • Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 3 years

  • Severity of TEAEs

    Time frame: Up to 3 years

  • Occurrence of Serious Adverse Events (SAEs)

    Time frame: Up to 3 years

  • Change from baseline score in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) scale

    Time frame: Up to 5 years

  • Change from baseline score in EORTC QLQ-C30 physical functioning scale

    Time frame: Up to 5 years

  • Change from baseline score in EORTC QLQ-C30 role functioning scale

    Time frame: Up to 5 years

  • Change from baseline score in EORTC QLQ-C30 emotional functioning scale

    Time frame: Up to 5 years

  • Change from baseline score in EORTC QLQ-C30 pain scale

    Time frame: Up to 5 years

  • Change from baseline score in EORTC QLQ-C30 fatigue scale

    Time frame: Up to 5 years

  • Change from baseline score in EORTC IL478 future perspectives scale

    Time frame: Up to 5 years

  • Change from baseline score in EuroQoL-5 Dimensions 5-Level Questionnaire Visual Analogue Scale (EQ-5D-5L VAS )

    Time frame: Up to 5 years

  • Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5) responses

    Time frame: Up to 5 years

  • Change from baseline in FACIT- Item GP5 score

    Time frame: Up to 5 years

  • Concentrations of linvoseltamab in serum

    Time frame: Up to 5 years

  • Occurrence of Anti-Drug Antibodies (ADAs) to linvoseltamab in serum

    Time frame: Up to 5 years

  • Magnitude of ADA to linvoseltamab in serum

    Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 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

Study locations (1)

Dana Farber / Harvard Cancer Center

Boston, Massachusetts, 02215

Recruiting
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) | Cancerify