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
Recruiting now · Phase 2
Conditions studied: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM)
In brief
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).
Key facts
- Study ID
- NCT06140524
- Run by
- Regeneron Pharmaceuticals
- People needed
- 116
- Starts
- 2024-09-16
- Expected to finish
- 2032-05-18
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan Health — Ann Arbor, Michigan, United States (enrolling)
- NYU Langone Health Perlmutter Cancer Center — New York, New York, United States (enrolling)
- Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
- University of Washington — Seattle, Washington, United States (enrolling)
- Algemeen Ziekenhuis (AZ) Klina — Brasschaat, Antwerpen, Belgium (enrolling)
- AZ St.-Elisabeth Herentals vzw — Herentals, Antwerp, Belgium (enrolling)
- AZ Sint Maarten Algemeen Ziekenhuis Emmaus — Mechelen, Flanders, Belgium (enrolling)
- Algemeen Ziekenhuis St Jan Brugge Oostende Av — Bruges, West-Vlaanderen, Belgium (enrolling)
- Algemeen Ziekenhuis AZ Delta — Roeselare, West-Vlaanderen, Belgium (enrolling)
- Ziekenhuis Netwerk Antwerpen Cadix, Hematology — Antwerp, Belgium (enrolling)
- Centre Hospitalier Universitaire De Poitiers — Poitiers, New Aquitaine, France (enrolling)
- Institut Curie — Paris, Île-de-France Region, France (enrolling)
- Galway University Hospital — Galway, Connacht, Ireland (enrolling)
- Cork University Hospital — Cork, Ireland (enrolling)
- Mater Misericordiae University Hospital — Dublin, Ireland (enrolling)
- Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori — Meldola, Forli-Cesena, Italy (enrolling)
- IRCCS Ospedale Policlinico San Martino — Genoa, Genova, Italy (enrolling)
- San Paolo Hospital — Milan, Lombardy, Italy (enrolling)
- Azienda Ospedaliero Universitaria (AOU) SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Piedmont, Italy (enrolling)
- UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno — Ascoli Piceno, Italy (enrolling)
- Universita degli Studi di Pavia - Fondazione IRCCS Policlini — Pavia, Italy (enrolling)
- Ospedale Santa Maria delle Croci — Ravenna, Italy (enrolling)
Full record on ClinicalTrials.gov
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