A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multip… (NCT07428369) | Clinical Trial Compass
WithdrawnPhase 2/3
A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)
Stopped: Sponsor Decision
0Started 2026-06-05
Plain-language summary
This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT).
This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR.
The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments.
The study is looking at several other research questions, including:
* What side effects may happen from taking linvoseltamab
* How much linvoseltamab is in the blood at different times
* Whether the body makes antibodies against the linvoseltamab (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
. Participants must have a histologically or cytologically confirmed diagnosis of multiple myeloma, which requires the presence of clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma, and at least one other criteria as defined by the SLiM (\>=60%, Light chains I/U \>10, Magnetic resonance imaging \>1 focal lesion) CRAB (Calcium elevation, Renal insufficiency, Anemia, Bone disease) criteria
. Participants must have measurable disease, as defined in the protocol
. Participants must be considered eligible for high-dose chemotherapy (melphalan) and ASCT per local standard guidelines
. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
. Must be willing to defer ASCT
Exclusion criteria
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 was withdrawn before enrolling anyone — does that mean the Linvo-VR combination being studied here is a dead end, or are there other active trials testing similar approaches for newly diagnosed multiple myeloma that I should know about?
2Since this trial was comparing Linvo-VR against DVRd (daratumumab, bortezomib, lenalidomide, and dexamethasone), can you tell me how DVRd performs as a standard treatment option for transplant-eligible patients like me, so I understand what the experimental arm was being measured against?
3The trial was designed to measure whether patients achieved complete response or MRD negativity at a very sensitive level (10^-5) — how important are those specific benchmarks in my own treatment planning, and should I be asking about MRD testing regardless of which treatment we choose?
4Because this study was withdrawn before it produced any safety or efficacy data, what do we actually know today about the safety profile of Linvo-VR from other sources, and does that information change how you'd think about my options?
5Given that I'm transplant-eligible and this trial was specifically designed for that group, which currently open studies or standard regimens would you recommend I consider instead, and how do their goals compare to what this trial was trying to measure?
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
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to day 112
2
Severity of TEAEs
Timeframe: Up to day 112
3
Achievement of Complete Response or better (≥CR) per International Myeloma Working Group (IMWG) criteria
Timeframe: Up to day 112
4
Minimal Residual Disease (MRD) negative CR at 10^-5 per IMWG criteria
. Any prior therapy for Monoclonal Gammopathy of Undetermined Significance (MGUS), Monoclonal Gammopathy of Renal Significance (MGRS), Smoldering Multiple Myeloma (SMM), or MM, with the exception of those defined in the protocol
. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM (or another plasma cell disorder), or those whose AEs due to agents administered earlier (such as radiation and/or corticosteroids) have not recovered to a severity of grade 0 or grade 1
. Participants with non-secretory MM, diagnosis of plasma cell leukemia (\>20% circulating plasma cells), symptomatic amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes).
. Participants who have known Central Nervous System (CNS) or meningeal involvement with MM or known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, Transient Ischemic Attack (TIA), or stroke within 12 months prior to study randomization
. Another malignancy besides MM that is progressive or has required treatment in the 3 years preceding randomization with the exceptions defined in the protocol