Back to Trials
NCT06140524PHASE2Recruiting

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

Regeneron Pharmaceuticals

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

Key Inclusion Criteria: 1. HR-MGUS or NHR-SMM as defined in the protocol 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 Key Exclusion Criteria: 1. High-risk SMM, as defined in the protocol 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 NOTE: Other protocol defined inclusion/exclusion criteria apply

Interventions

DRUG

Linvoseltamab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS)Smoldering Multiple Myeloma (SMM)

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