A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myelo… (NCT07393282) | Clinical Trial Compass
RecruitingPhase 3
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
United States270 participantsStarted 2026-05-21
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing linvoseltamab to daratumumab specifically for high-risk smoldering myeloma — which means my disease hasn't fully progressed yet — so can you help me understand whether treating now with either of these drugs is likely better for me than a careful watch-and-wait approach?
2Since this is a Phase 3 trial, there should be earlier-phase safety data on both linvoseltamab and daratumumab — what are the most important side effects I should know about with each drug, and how do they compare in terms of risk?
3The trial is measuring two types of progression-free survival — one based on clinical symptoms and one based on lab markers — can you explain what those distinctions mean for how my disease would actually be monitored if I took part?
4Since the trial is actively recruiting, what would participation realistically look like for my daily life — how often would I need to come in for treatment or monitoring, and are there logistical demands I should think through before deciding?
5Is there any standard-of-care treatment already approved for high-risk smoldering myeloma that I should consider first, or would joining this trial mean I'd potentially access something that isn't yet available outside of a study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
. 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.