Multiple Myeloma Clinical Trials

• Age ≥ 18 years at the time of signing the informed consent form (ICF).

• Body mass index (BMI): 18.5 kg/m2 ≤ BMI \< 28 kg/m2.

• Subjects must participate voluntarily, understand the study, and sign the ICF.

• Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion .

• Serum albumin ≥ 35 g/L.

• Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator.

• The patient's ECOG performance status must be 0 or 1 .

• Patient must have clinical laboratory values meeting the following criteria during the screening period:

∙ Hemoglobin ≥ 7.5 g/dL (≥ 5 mmol/L; red blood cell \[RBC\] transfusion or use of recombinant human erythropoietin at least 1 week prior to randomization is allowed).

‣ Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (use of granulocyte-colony stimulating factor \[G-CSF\] is allowed).

‣ Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).

‣ Without the following evidence of impaired liver function, including mild impairment (total bilirubin ≤ ULN and AST \> ULN or ULN \< total bilirubin ≤ 1.5 x ULN), moderate impairment (1.5 x ULN \< total bilirubin ≤ 3 x ULN), and severe impairment (total bilirubin \> 3 x ULN).

‣ Measured creatinine clearance ≥ 40 mL/min .

‣ Corrected serum calcium \< 14 mg/dL (\< 3.5 mmol/L); or free ionized calcium \< 6.5 mg/dL (\< 1.6 mmol/L) .

‣ Platelet count ≥ 70 × 109/L for patients with plasma cells \< 50% of bone marrow nucleated cells; platelet count \> 50 × 109/L for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted).

• Contraceptive criteria: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

∙ Female patients: a female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

∙ Not a woman of childbearing potential (WOCBP) or WOCBP: must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously from signed ICF to at least 140 days following the last dose of study products. This includes one highly effective contraceptive method with a failure rate of \< 1% per year (tubal ligation, intrauterine device, hormonal \[birth control pills, injections, hormonal patches, vaginal rings or implants\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.

∙ The subjects also need to agree not to donate or cryopreservation eggs (ova, oocytes) from signed ICF to at least 140 days following the last dose of study products.

‣ Male patients: male patients are eligible to participate if they agree to the following during the intervention period and for at least 140 days following the last dose of study products:

• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.

• or Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.

• Agree not to donate or cryopreservation sperm.

⁃ A WOCBP must have a negative serum pregnancy test at screening within 72 h prior to randomization. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy