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
Start Date
9/16/2024
Completion Date
5/18/2032
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Linvoseltamab
Conditions
Locations
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Michigan Health
Ann Arbor, Michigan 48109
United States
NYU Langone Health Perlmutter Cancer Center
New York, New York 10016
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
University of Washington
Seattle, Washington 98109
United States
Algemeen Ziekenhuis (AZ) Klina
Brasschaat, Antwerpen 2930
Belgium
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp 2200
Belgium
AZ Sint Maarten Algemeen Ziekenhuis Emmaus
Mechelen, Flanders 2800
Belgium
Algemeen Ziekenhuis St Jan Brugge Oostende Av
Bruges, West-Vlaanderen 8000
Belgium
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen 8800
Belgium
Ziekenhuis Netwerk Antwerpen Cadix, Hematology
Antwerp, 2030
Belgium
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine 86000
France
Institut Curie
Paris, Île-de-France Region 75005
France
Galway University Hospital
Galway, Connacht H91 YR71
Ireland
Cork University Hospital
Cork, T12 EC8P
Ireland
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Ireland
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena 47014
Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Genova 16132
Italy
San Paolo Hospital
Milan, Lombardy 20142
Italy
Azienda Ospedaliero Universitaria (AOU) SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont 15121
Italy
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
Ascoli Piceno, 63100
Italy
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, 27100
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship 58-309
Poland
Pratia MCM Krakow
Krakow, Malopolska 30-510
Poland
University Clinical Center / Medical University of Gdansk
Gdansk, Pomeranian Voivodeship 80-219
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, 93-513
Poland
Swietokrzyskie Centrum Onkologii
Kielce, Świętokrzyskie Voivodeship 25-734
Poland
Hospital Universitario Virgen de las Nieves
Granada, Andalusia 18014
Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona 08221
Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia 30120
Spain
Hospital de Cabuenes
Gijón, Principality of Asturias 33203
Spain
Hospital Sant Pau
Barcelona, 08041
Spain
Institut Catala dOncologia (ICO Hospitalet)
Barcelona, 08908
Spain
Universitaru Hospital La Princesa
Madrid, 28006
Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008
Spain