A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linvoseltamab, Daratumumab.
- Who it may be relevant to
- Registry conditions: High Risk Smoldering Multiple Myeloma (HR-SMM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
Overview
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)
Interventions
- Drug Linvoseltamab
Administered per the protocol - Drug Daratumumab
Administered per the protocol
Primary outcome measures
- 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 outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- Eastern Cooperative Oncology Group performance status score ≤1
- SMM diagnosis per IMWG criteria as defined in the protocol
- Meets HR-SMM criteria by 1 of the risk models as defined in the protocol
Exclusion criteria
- Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol
- Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma
- History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
- History of a seizure within the 12 months of randomization
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Emory University - Winship Cancer Institute — Atlanta
- Dana Farber / Harvard Cancer Center — Boston
- Karmanos Cancer Institute — Detroit
Identifiers
NCT: NCT07393282 · R5458-HM-24145 · 2025-523252-31-00