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 as measured by progression-free survival (PFS) per blinded independent review committee (IRC).

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 (31)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

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

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

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

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

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

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 Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Epworth HealthCare

Richmond, Victoria, Australia, 3121

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

Linz, Austria

University Hospital St. Poelten, Department of Internal Medicine I

St. Poelten, Austria, 3100

CHU de Toulouse. IUCT Oncopole

Toulouse, France, 31100

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

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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