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.
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
Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
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
Parallel
Anitocabtagene Autoleucel
DrugA single infusion of CAR+ transduced autologous T cells
Cyclophosphamide
DrugAdministered intravenously
Fludarabine
DrugAdministered intravenously
Pomalidomide
DrugTablet administered orally
Bortezomib
DrugAdministered intravenously or subcutaneously
Dexamethasone
DrugTablet administered orally
Daratumumab
DrugAdministered intravenously or subcutaneously
Carfilzomib
DrugAdministered intravenously
Progression-Free Survival (PFS)
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
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.
CR Rate (CR/ Stringent Complete Response (sCR))
CR rate is defined as the proportion of participants who achieved a best overall response of CR or sCR per IMWG criteria as determined by IRC.
Overall MRD Negativity
Overall MRD negativity, defined as the proportion of any MRD negativity in participants with bone marrow aspirate (\< 1 in 10\^5 nucleated cells per IMWG criteria using next-generation sequencing (NGS)) at any time after randomization until disease progression, subsequent anti-multiple myeloma (MM) therapy, or death.
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, very good partial response (VGPR), or PR) per IMWG criteria.
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Kite, A Gilead Company
Lead sponsor
Arcellx, Inc.
Collaborator
