Tests linvoseltamab in adults with precancerous plasma cell conditions
Tests linvoseltamab in adults with high-risk MGUS or smoldering multiple myeloma.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Antwerp, Brasschaat, Brugge, Herentals, Mechelen, and Roeselare, BelgiumSee the 6 sites
- Phase
- Phase 2
Where in Belgium
- Ziekenhuis Aan De StroomAntwerp, BelgiumTaking people
- Algemeen Ziekenhuis klinaBrasschaat, BelgiumTaking people
- Az St-Jan Brugge-Oostende A.V.Brugge, BelgiumTaking people
- AZ St.-Elisabeth Herentals vzwHerentals, BelgiumTaking people
- EmmauesMechelen, BelgiumTaking people
- Algemeen Ziekenhuis DeltaRoeselare, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT06140524EU 2023-505242-25-00
- Record updated
- 8 July 2026
- Original description
This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).Read full original descriptionShow less
Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).
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).
Inclusion: HR-MGUS or NHR-SMM as defined in the protocol; Eastern Cooperative Oncology Group (ECOG) performance status ≤1; Adequate hematologic and hepatic function, as described in the protocol; Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation.
Exclusion: Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab; Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol; 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; NOTE: Other protocol defined inclusion/exclusion criteria apply; High-risk SMM, as defined in the protocol; Evidence of any of myeloma-defining events, as described in the protocol; Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM.