Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients

Arms (1)

1. type

   EXPERIMENTAL

   label

   BiRd combined with BCMA CAR T-cells infusion

   interventionNames

   1. Drug: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells

Primary outcomes (1)

1. measure

   Overall response rate (ORR)

   timeFrame

   4 weeks after CAR T-cells infusion (up to 14 weeks)

   description

   ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, respectively, after counting ≥100 plasma cells). Complete Response (CR)：negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Very good partial response (VGPR)：serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. Partial response (PR): ≥50% reduction of serum M-protein plus reduction in 24 h urine M-protein by ≥90% or to \<200 mg per 24 h.