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New myeloma drug combo aims to replace stem cell transplants
NCT ID NCT07428369
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to test a new drug called linvoseltamab combined with standard chemotherapy drugs (bortezomib and lenalidomide) in people newly diagnosed with multiple myeloma who are eligible for a stem cell transplant. The goal was to see if this combination, with or without a transplant, works better than the current standard treatment. However, the trial was withdrawn before any participants were enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- linvoseltamab (with bortezomib and lenalidomide)
- What this could lead to
- If successful, this could offer a new combination therapy for multiple myeloma that might reduce the need for stem cell transplants.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no results are available. The approach is still experimental and may not prove better than current treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2038
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. 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 2. Participants must have measurable disease, as defined in the protocol 3. Participants must be considered eligible for high-dose chemotherapy (melphalan) and ASCT per local standard guidelines 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 5. Must be willing to defer ASCT Key Exclusion Criteria: 1. 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 2. 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 3. 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). 4. 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 5. Another malignancy besides MM that is progressive or has required treatment in the 3 years preceding randomization with the exceptions defined in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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