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NCT05828511PHASE1, PHASE2Recruiting

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

Regeneron Pharmaceuticals

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

Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 2. Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol 3. Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol 4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol 5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol 6. Participants must be age \<70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance. Key Exclusion Criteria: 1. Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis 2. Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment 3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy 4. Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes) Note: Other protocol-defined Inclusion/Exclusion criteria apply

Interventions

DRUG

Linvoseltamab

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Conditions

Multiple Myeloma

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