RecruitingPhase 3NCT06413498

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor

Kite, A Gilead Company

Enrollment

450 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new CAR T-cell therapy (anitocabtagene autoleucel) to standard treatment in patients with multiple myeloma (a cancer of plasma cells in the bone marrow) that has come back or stopped responding to prior treatments. CAR T-cell therapy is a cutting-edge approach where a patient's own immune cells are genetically re-engineered to attack cancer. **You may be eligible if...** - You have been previously diagnosed with multiple myeloma - You have received 1 to 3 prior lines of treatment, including specific drug types (an IMiD drug and an anti-CD38 antibody) - Your myeloma has progressed (gotten worse) within 12 months of your last treatment - You have measurable disease at the time of screening **You may NOT be eligible if...** - You have had more than 3 prior lines of therapy - Your disease has not progressed recently - You have not received the specific required prior medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnitocabtagene Autoleucel

A single infusion of CAR+ transduced autologous T cells

DRUGCyclophosphamide

Administered intravenously

DRUGFludarabine

Administered intravenously

DRUGPomalidomide

Tablet administered orally

DRUGBortezomib

Administered intravenously or subcutaneously

DRUGDexamethasone

Tablet administered orally

DRUGDaratumumab

Administered intravenously or subcutaneously

DRUGCarfilzomib

Administered intravenously

Locations(124)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic Hospital

Gilbert, Arizona, United States

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Diego Moores Cancer Center

San Diego, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

UCLA Hematology/Oncology (Bowyer Infusion Clinic)

Santa Monica, California, United States

Stanford Cancer Institute

Stanford, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Sylvester Comprehensive Cancer Center

Coral Gables, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta

Newnan, Georgia, United States

St. Luke's Cancer Institute

Boise, Idaho, United States

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States

IU Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States

Ochsner Clinical Foundation

New Orleans, Louisiana, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Corewell Health - Lemmen-Holton Cancer Pavilion

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

New Mexico Cancer Research Alliance

Albuquerque, New Mexico, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Weill Cornell Medicine - New York Presbyterian Hosptial

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Novant Health Cancer Institute - Hematology

Charlotte, North Carolina, United States

Novant Health Cancer Institute Hematology- Forsyth

Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

Nashville, Tennessee, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Houston Methodist Hospital Cancer Center

Houston, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Swedish Cancer Institute

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Epworth HealthCare

Richmond, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie

Linz, Austria

Paracelsus Medizinischen Privatuniversitaet

Salzburg, Austria

University Hospital St. Poelten, Department of Internal Medicine I

Sankt Pölten, Austria

Medical University of Vienna

Vienna, Austria

Cliniques Universitaires Saint-Luc

Brussels, Belgium

University Hospital of Antwerp

Edegem, Belgium

UZ Leuven

Flemish Brabant, Belgium

UZ Gent

Gent Oost-Vlaanderen, Belgium

QEII Health Sciences Centre

Halifax, Canada

McGill University Health Center

Montreal, Canada

The Ottawa Hospital - General Campus

Ottawa, Canada

University Health Network - The Princess Margaret Cancer Centre

Toronto, Canada

Fakultni Nemocnice Ostrava

Severomoravsky KRAJ, Czechia

CHU de Lille- Hopital Claude Huriez

Lille, France

Institut Paoli Calmettes

Marseille, France

CHU De Montpellier - Hopital Saint Eloi

Montpellier, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

Hopital Saint Louis

Paris, France

Hopital Saint Antoine

Paris, France

Hôpital Lyon Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

CHU de Rennes

Rennes, France

CHU de Toulouse. IUCT Oncopole

Toulouse, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitatsklinikum Koln, Klinik I fOr lnnere Medizin

Cologne, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitatsklinikum Leipzig

Leipzig, Germany

TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie

München, Germany

Universitatsklinikum Wurzburg

Tübingen, Germany

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, Italy

IRCCS AOU di Bologna

Bologna, Italy

Ospedale San Raffaele

Milan, Italy

Policlinico Universitario Argostino Gemelli

Roma, Italy

AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette

Torino, Italy

Hyogo Medical University Hospital

Hyōgo, Japan

Nagoya City University Hospital

Nagoya, Japan

The University of Osaka Hospital

Osaka, Japan

Hamamatsu University Hospital

Shizuoka, Japan

Jichi Medical University Hospital

Tochigi, Japan

Juntendo University School of Medicine Juntendo Clinic

Tokyo, Japan

Japanese Red Cross Medical Center

Tokyo, Japan

Amsterdam UMC - Location vUmc

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland

Instytut Hematologii i Transfuzjologii

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Poland

ICO Badalona-H.U. Germans Trias i Pujol

Badalona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Duran i Reynals

Barcelona, Spain

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Inselspital - Universitätsspital Bern

Bern, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre

Bristol, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Leeds Teaching Hospitals NHS Trust, St James's University Hospital

Leeds, United Kingdom

King's College Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

Newcastle, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06413498

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