Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

JRCT ID: jRCT2043240170

Registered date:20/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Relapsed/Refractory Multiple Myeloma
• Date of first enrollment: 01/05/2025
• Target sample size: 450
• Countries of recruitment: America,Japan,Australia,Japan,Europe,Japan
• Study type: Interventional
• Intervention(s): Participants in the anitocabtagene autoleucel arm will receive a single infusion of anitocabtagene autoleucel.Participants in the SOCT arm will receive the investigators choice of Pvd,DPd,LDd,orKd.

Outcome(s)

• Primary Outcome: PFS,defined as the time from randomization to disease progression per IMWG criteria as determined by IRC,or death due to any cause,whichever occurs first.

Secondary Outcome

-Complete Response (CR) Rate (CR/ Stringent Complete Response (sCR))
-Overall Minimal Residual Disease (MRD) Negativity
-Overall survival (OS)
-Overall Response Rate (ORR)
-MRD-negative CR/sCR
-MRD-negative VGPR+
-Sustained MRD Negativity
-Duration of Response (DOR)
-Time to Progression
-Time to Next Treatment
-Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
-Percentage of Participants With Anti-Anitocabtagene Autoleucel CAR Antibodies (Anitocabtagene Autoleucel Arm)
-Percentage of Participants With Presence of Replication-Competent Lentivirus (Anitocabtagene Autoleucel Arm)
-Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
-Change From Baseline in the EORTC - Multiple Myeloma Module (EORTC QLQ-MY20) Score
-Change From Baseline in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Score
-Percentage of Participants Using Healthcare Resources

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Documented historical diagnosis of multiple myeloma (MM)
2.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.
3.Documented evidence of progressive disease by IMWG criteria based on the investigator of determination on or within 12 months of the last dose of the last regimen
4.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
5.Only individuals who are candidates to receive at least 1 of the SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7.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)

Exclude criteria

1.Prior B-cell maturation antigen (BCMA)-targeted therapy
2.Prior T-cell engager therapy
3.Prior CAR therapy or other genetically modified T-cell therapy
4.Active or prior history of central nervous system (CNS) or meningeal involvement of MM
5.Cardiac atrial or cardiac ventricular MM involvement
6.History of or active plasma cell leukemia, Waldenstrom of macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
7.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.
8.Prior auto-SCT within 12 weeks before randomization
9.Prior allogeneic stem cell transplant (allo-SCT)
10.High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
11.Live vaccine <_ 4 weeks before randomization
12.Contraindication to fludarabine or cyclophosphamide
13.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.
14.Life expectancy < 12 weeks

Related Information

• Primary Sponsor: Asou Hiroya
• Secondary ID(s): NCT06413498,2024-511188-26