This is a prospective, single-center, clinical study to evaluate the efficacy and safety of a fully immunotherapy-based strategy guided by MRD-driven dynamic risk stratification in transplant-ineligible patients with newly diagnosed multiple myeloma.
Age ≥ 18 years and ≤ 75 years.
Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.
Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
Patients deemed ineligible for high-dose chemotherapy with ASCT due to any of the following: Age ≥65 years; Investigator assessment of ineligibility; ECOG performance status 3-4; Repeated failure of hematopoietic stem cell mobilization; Patient's decision to defer ASCT.
Active amyloidosis.
Central nervous system involvement.
Prior BCMA-targeted therapy or CAR-T therapy.
Active hepatitis B or hepatitis C virus infection.
Parallel
BCMA CAR-T
Biological/VaccinePatients will receive single-dose infusion of autologous BCMA-directed CAR-T cellsBCMA CAR-T single dose (3.0 x 10\^6 cells /kg).
GPRC5D/CD3 BiTEs
DrugPatients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion.
Sustained MRD-negative rate
Rate of patients achieving sustained MRD negativity for more than 12 months
Progression free survival (PFS)
Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Complete response rate (CRR)
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria.
MRD negativity rate
Rate of patients achieving MRD negativity
Overall survival (OS)
Overall survival is defined as the time from the date of diagnosis to the date of death due to any cause
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