Anitocabtagene Autoleucel: A single infusion of CAR+ transduced autologous T cells
Cyclophosphamide: Administered intravenously
Fludarabine: Administered intravenously
Pomalidomide: Tablet administered orally
Bortezomib: Administered intravenously or subcutaneously
Dexamethasone: Tablet administered orally
Daratumumab: Administered intravenously or subcutaneously
Carfilzomib: Administered intravenously
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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)
Key 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.
Primary outcome measure(s)
Progression-Free Survival (PFS) — Up to 4 years PFS is defined as the time from randomization to disease progression per International Myeloma Working Group (IMWG) criteria as determined by independent review committee (IRC), or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD) Complete Response (CR) Rate at 9 Months — Up to 9 months Minimal MRD is defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (\< 1 in 105 nucleated cells per IMWG criteria using NGS) (Kumar 2016). CR/sCR per IMWG criteria is determined by IRC.
Trial sites (117)
Facility
City
Region
Status
Banner MD Anderson Cancer Center
Gilbert
Arizona
Mayo Clinic Hospital
Gilbert
Arizona
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte
California
USC/Norris Comprehensive Cancer Center
Los Angeles
California
University of California Davis Comprehensive Cancer Center
Sacramento
California
UC San Diego Moores Cancer Center
San Diego
California
UCLA Hematology/Oncology (Bowyer Infusion Clinic)
Santa Monica
California
Stanford Cancer Institute
Stanford
California
Colorado Blood Cancer Institute
Denver
Colorado
Sylvester Comprehensive Cancer Center
Coral Gables
Florida
Mayo Clinic
Jacksonville
Florida
Moffitt Cancer Center
Tampa
Florida
Winship Cancer Institute, Emory University
Atlanta
Georgia
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan
Georgia
St. Luke's Cancer Institute
Boise
Idaho
University of Illinois Hospital and Health Sciences System
Chicago
Illinois
IU Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis
Indiana
Norton Cancer Institute, St. Matthews Campus
Louisville
Kentucky
Ochsner Clinical Foundation
New Orleans
Louisiana
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore
Maryland
Massachusetts General Hospital
Boston
Massachusetts
Boston Medical Center
Boston
Massachusetts
University of Michigan
Ann Arbor
Michigan
Corewell Health - Lemmen-Holton Cancer Pavilion
Grand Rapids
Michigan
Mayo Clinic
Rochester
Minnesota
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha
Nebraska
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
New Mexico Cancer Research Alliance
Albuquerque
New Mexico
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York
New York
Weill Cornell Medicine - New York Presbyterian Hosptial
New York
New York
Icahn School of Medicine at Mount Sinai
New York
New York
Levine Cancer Institute
Charlotte
North Carolina
Novant Health Cancer Institute Hematology- Forsyth
Winston-Salem
North Carolina
University of Cincinnati Cancer Center
Cincinnati
Ohio
Oregon Health and Science University
Portland
Oregon
University of Tennessee Medical Center
Knoxville
Tennessee
Baptist Cancer Center
Memphis
Tennessee
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research
Nashville
Tennessee
Henry-Joyce Cancer Clinic
Nashville
Tennessee
St. David's South Austin Medical Center
Austin
Texas
+ 77 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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