Trattamento

Experimental: Anitocabtagene Autoleucel
Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1. Drug: Anitocabtagene Autoleucel

• A single infusion of CAR+ transduced autologous T cells
• Other Names:
  • CART-ddBCMA

Drug: Cyclophosphamide

• Administered intravenously

Drug: Fludarabine

• Administered intravenously

Active Comparator: Standard of Care Therapy (SOCT)
Participants will receive the investigator’s choice of one of the following therapies:

• pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles)
• daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles)
• carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles)
• carfilzomib and dexamethasone (Kd) (28-day cycles)

Drug: Pomalidomide

• Tablet administered orally

Drug: Bortezomib

• Administered intravenously or subcutaneously

Drug: Dexamethasone

• Tablet administered orally

Drug: Daratumumab

• Administered intravenously or subcutaneously

Drug: Carfilzomib

• Administered intravenously

Obiettivo primario

1. Progression-Free Survival (PFS) [ Time Frame: 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. Up to 4 years
2. Minimal Residual Disease (MRD) Complete Response (CR) Rate at 9 Months [ Time Frame: 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.