A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
NCT ID: NCT06140524
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
116 participants
INTERVENTIONAL
2024-09-16
2032-05-18
Brief Summary
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The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.
The study is looking at several other research questions, including:
* How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM?
* 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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety Run-In (Part 1)
Sequential groups of participants will be enrolled to assess the initial safety and tolerability of the step-up regimen leading up to the start of different full doses of linvoseltamab.
Linvoseltamab
Administered per the protocol
Expansion (Part 2) - Dose regimen 1
Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Linvoseltamab
Administered per the protocol
Expansion (Part 2) - Dose regimen 2
Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Linvoseltamab
Administered per the protocol
Expansion (Part 2) - Dose regimen 3
Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Linvoseltamab
Administered per the protocol
Expansion (Part 2) - Dose regimen 4
Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Linvoseltamab
Administered per the protocol
Interventions
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Linvoseltamab
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation
Exclusion Criteria
2. Evidence of any of myeloma-defining events, as described in the protocol
3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab
6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health
Ann Arbor, Michigan, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain
Hospital de Cabuenes
Gijón, Principality of Asturias, Spain
Hospital Sant Pau
Barcelona, , Spain
Universitaru Hospital La Princesa
Madrid, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Countries
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Central Contacts
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Other Identifiers
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2023-505242-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
R5458-ONC-2257
Identifier Type: -
Identifier Source: org_study_id
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