F182112 in Combination With Isatuximab and Lenalidomide for the Treatment of Patients With Newly Diagnosed Multiple Myeloma

Prior treatment

• Patients with severe and/or uncontrolled cardiac disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, or severe and uncontrolled arrhythmia; or other cardiovascular or cerebrovascular diseases that, in the investigator's judgment, make the patient unsuitable for participation in this study.
• Patients with concurrent other malignancies; or patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or affect the patient's ability to complete the study.
• Trial participants who have undergone major surgery, such as surgery requiring general anesthesia, within 2 weeks prior to enrollment; who will not have fully recovered from surgery; or who are scheduled to undergo surgery during the planned study period. Kyphoplasty or vertebroplasty is not considered major surgery.
  • Note:\*\* Trial participants scheduled to undergo surgical procedures under local anesthesia may participate in the study.

Other illness

• Diagnosed with smoldering multiple myeloma, POEMS syndrome, amyloidosis, or plasma cell leukemia.
• Presence of active infection, including HIV positivity; active hepatitis B infection (HBV-DNA positive); active hepatitis C infection (HCV-RNA positive); active or latent syphilis infection (positive Treponema pallidum antibody); active pulmonary tuberculosis, as indicated by chest imaging or other relevant examinations within the past 3 months or during the screening period; or other infections that, in the investigator's judgment, make the patient unsuitable for participation in this study.
• Contraindication to, or life-threatening allergy, hypersensitivity, or intolerance to, any study drug or excipient.
• Any active severe psychiatric disorder, medical disease, or other symptom/condition that, in the investigator's judgment, may affect treatment, compliance, or the ability to provide informed consent.
• Other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.

Other

• Presence of central nervous system involvement.
• Pregnant or breastfeeding women.
• Life expectancy \<6 months.
• Unable or unwilling to sign the informed consent form.

• Trial participants must voluntarily sign the informed consent form (ICF).
• Aged 18-70 years.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2.
• Diagnosed with newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease. At least one of the following criteria must be met:
  • 1\. Serum M-protein level ≥1.0 g/dL; 2. Urine M-protein level ≥200 mg/24 hours; 3. Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio.
  • 5\. Previously received no more than one course of systemic therapy. 6. Liver function tests must meet the following criteria: total bilirubin \<1.5 × upper limit of normal (ULN) (total bilirubin \<3 × ULN for patients with Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 × ULN.
  • 7\. Renal function must meet the following criterion: creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
  • 8\. Complete blood count within 14 days prior to the start of screening must meet the following criteria: white blood cell (WBC) count ≥1.0 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, hemoglobin ≥70 g/L, and platelet count ≥50 × 10⁹/L; or the investigator determines that the participant is suitable for enrollment based on the actual clinical situation.
  • 9\. For patients receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and platelet agonists, etc. (e.g., eltrombopag, TPO, interleukin-11), there must be an interval of 2 weeks between receiving growth factor support and screening assessment.
  • 10\. The patient is able to receive the prophylactic anticoagulation therapy recommended by the study.
  • 11\. Women of non-childbearing potential are eligible for enrollment; female patients of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) or urine pregnancy test at screening.
  • 12\. Male patients, women of childbearing potential, and their partners must voluntarily use effective contraceptive measures, as deemed appropriate by the investigator, during treatment and for at least 3 months after treatment.
  • 13\. Male patients must agree not to donate sperm from the initial screening period until 90 days after the last dose.
  • \*\*Note:\*\* Women of childbearing potential are defined as all women who have experienced menarche and are not postmenopausal and have not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). Postmenopausal status is defined as amenorrhea for more than 12 consecutive months without another specified cause. Women using mechanical contraceptive methods such as oral contraceptives or intrauterine devices should be considered to have childbearing potential. Male trial participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must have no plan to impregnate a female partner from the date of signing the informed consent form, throughout the use of the investigational drug, and for 3 months after the last administration of the investigational drug.