A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Start Date
12/19/2023
Completion Date
11/2/2035
Summary
This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible). The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM. This study consists of 2 phases: * In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2. * In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug. * In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM. The study is looking at several research questions, including: * What side effects may happen from taking linvoseltamab? * What the right dosing regimen is for linvoseltamab? * How many participants treated with linvoseltamab have improvement of their disease and for how long? * The effects of linvoseltamab study treatment before and after transplant * How much linvoseltamab is in the blood at different times? * Whether the body makes antibodies against linvoseltamab (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
University of California Los Angeles (UCLA)
Los Angeles, California 90095
United States
UC Irvine Health
Orange, California 92868
United States
Colorado Blood Cancer Institute/SCRI
Denver, Colorado 80218
United States
Norton Cancer Institute
Louisville, Kentucky 40207
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Perlmutter Cancer Center
New York, New York 10016
United States
Columbia University _ New York Presbyterian
New York, New York 10032
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Duke University Health System (DUHS)
Durham, North Carolina 27705
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Vienne 86021
France
CHU De Lille
Lille, 59000
France
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, 342950
France
Hopital Saint Louis
Paris, 75010
France
University Hospitals Pitie Salpetriere - Charles Foix
Paris, 75651
France
Hopital Prive d'Antony
Antony, Île-de-France Region 92160
France
Hopital Necker
Paris, Île-de-France Region 75015
France
Gustave Roussy
Villejuif, Île-de-France Region 94800
France
Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
Spain
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
Clinica Universidad de Navarra
Pamplona, Navarre 31008
Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias 33011
Spain
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia 03010
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Institut Catala dOncologia (ICO Hospitalet)
Barcelona, 08908
Spain
Universitary Hospital La Princesa
Madrid, 28006
Spain
Clinica Universidad de Navarra - Madrid
Madrid, 28027
Spain
Hospital Universitario de Salamanca
Salamanca, 37007
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain