CM336-SOC for Dynamically High-Risk Multiple Myeloma Study

Inclusion criteria

• . Able to understand and voluntarily sign the informed consent form (ICF).
• . Aged ≥18 and ≤75 years.
• . Has measurable disease, meeting at least one of the following criteria: serum M-protein ≥5 g/L as measured by serum protein electrophoresis (SPEP); or, for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead; or urine M-protein ≥200 mg/24 hours; if neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg/L in the presence of an abnormal serum FLC ratio (normal FLC ratio: 0.26 to 1.65).
• . Has received only one prior line of standard anti-myeloma therapy: standard induction therapy comprising at least two of the following: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; followed by autologous hematopoietic stem cell transplantation or consolidation therapy, and standard maintenance therapy.
• . Meets the definition of functional high-risk multiple myeloma according to the EMN consensus: disease progression or relapse within 18 months after initiation of any first-line therapy.
• . Liver function tests meet the following criteria: total bilirubin \<1.5 × upper limit of normal (ULN) (except that patients with Gilbert's syndrome must have total bilirubin \<3 × ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.
• . Renal function tests meet the following criterion: creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
• . Complete blood count within 7 days before screening meets the following criteria: white blood cell (WBC) count ≥1.5 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, hemoglobin ≥70 g/L, and platelet count ≥75 × 10⁹/L if bone marrow plasma cells are \<50%, or platelet count ≥50 × 10⁹/L if bone marrow plasma cells are ≥50%; or, in the investigator's judgment based on the actual clinical situation, the subject is considered suitable for enrollment.