Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Multiple Myeloma

Gender

N/A

Date

August 2024 - July 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib

Eligibility Information

Inclusion Criteria

Documented historical diagnosis of multiple myeloma (MM)
Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
Measurable disease at screening per IMWG, defined as any of the following:
Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

Exclusion Criteria

Prior B-cell maturation antigen (BCMA)-targeted therapy
Prior T-cell engager therapy
Prior CAR therapy or other genetically modified T-cell therapy
Active or prior history of central nervous system (CNS) or meningeal involvement of MM
Cardiac atrial or cardiac ventricular MM involvement
History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
Prior auto-SCT within 12 weeks before randomization
Prior allogeneic stem cell transplant (allo-SCT)
High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
Live vaccine ≤ 4 weeks before randomization
Contraindication to fludarabine or cyclophosphamide
History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
Life expectancy < 12 weeks
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (84)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

UC San Diego Moores Cancer Center

San Diego, California, United States, 92037

University of California San Francisco Medical Center

San Francisco, California, United States, 94143

UCLA Department of Medicine-Hematology/Oncology

Santa Monica, California, United States, 90404

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

IU Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States, 40207

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Boston Medical Center

Boston, Massachusetts, United States, 02118

University of Michigan

Ann Arbor, Michigan, United States, 48109

Corewell Health - Lemmen-Holton Cancer Pavilion

Grand Rapids, Michigan, United States, 49503

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States, 87102

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

Novant Health Cancer Institute Hematology

Charlotte, North Carolina, United States, 28204

Novant Health Cancer Institute Hematology- Forsyth

Winston-Salem, North Carolina, United States, 27103

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Oregon Health and Science University

Portland, Oregon, United States, 97239

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Baptist Cancer Center

Memphis, Tennessee, United States, 38104

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

Houston Methodist Hospital Cancer Center

Houston, Texas, United States, 77030

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

LDS Hospital

Salt Lake City, Utah, United States, 84143

Swedish Cancer Institute

Seattle, Washington, United States, 98104

University of Washington Medical Center

Seattle, Washington, United States, 98109

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, NSW 2050

Royal North Shore Hospital

St. Leonards, New South Wales, Australia, 2065

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Epworth HealthCare

Richmond, Victoria, Australia, 3121

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

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

Linz, Austria

Paracelsus Medizinischen Privatuniversitaet

Salzburg, Austria, A-5020

University Hospital St. Poelten, Department of Internal Medicine I

St. Poelten, Austria, 3100

University Hospital of Antwerp

Edegem, Belgium

UZ Leuven

Flemish Brabant, Belgium, 3000

UZ Gent

Gent Oost-Vlaanderen, Belgium, 9000

QEII Health Sciences Centre

Grande Prairie, Canada, T8V2E8

University Health Network - The Princess Margaret Cancer Centre

Toronto, Canada, M5G 2M9

CHU de Lille- Hopital Claude Huriez

Lille, France, 59037

Institut Paoli Calmettes

Marseille, France, 13273

CHU De Montpellier - Hopital Saint Eloi

Montpellier, France, 34080

Centre Hospitalier Universitaire de Nantes

Nantes, France, 44093

Hopital Saint Louis

Paris, France, 75010

Hopital Saint Antoine

Paris, France, 75571

Hôpital Lyon Sud

Pierre-Benite, France, 69495

Centre Hospitalier Universitaire de Poitiers

Poitiers, France, 86021

CHU de Rennes

Rennes, France, 59037

CHU de Toulouse. IUCT Oncopole

Toulouse, France, 31100

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany, 20246

Universitatsklinikum Koln, Klinik I fOr lnnere Medizin

Köln, Germany

Universitatsklinikum Leipzig

Leipzig, Germany, 4103

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

München, Germany, 80333

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, Italy, 20133

IRCCS AOU di Bologna

Bologna, Italy, 40138

Hyogo Medical University Hospital

Hyogo, Japan, 663-8501

Nagoya City University Hospital

Nagoya City, Japan, 467-8602

The University of Osaka Hospital

Osaka, Japan, 565-0871

Hamamatsu University Hospital

Shizuoka, Japan, 431-3192

Jichi Medical University Hospital

Tochigi, Japan, 329-0498

Juntendo University School of Medicine Juntendo Clinic

Tokyo, Japan, 113-8431

Japanese Red Cross Medical Center

Tokyo, Japan, 150-8935

Amsterdam UMC - Location vUmc

Amsterdam, Netherlands, 1081 HV

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Hospital Clínic de Barcelona

Barcelona, Spain, 08036

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Spain, 30120

Hospital Universitario Ramon Y Cajal

Madrid, Spain, 28034

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Clinica Universidad de Navarra

Pamplona, Spain, 31008

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain, 37007

Hospital Universitario Marqués de Valdecilla

Santander, Spain, 39008

Hospital Universitario Virgen del Rocio

Seville, Spain, 41013

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Inselspital - Universitätsspital Bern

Berne, Switzerland, 3010

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland, CH-1011

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

Bristol, United Kingdom, BS2 8ED

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

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

Leeds, United Kingdom, LS9 7TF

University College London Hospital

London, United Kingdom, WC1E 6JN

Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

Newcastle, United Kingdom, NE7 7DN

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (iMMagine-3)

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