This is a prospective, single-center, single-arm, exploratory pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of F182112 in combination with isatuximab and lenalidomide in transplant-eligible patients with newly diagnosed multiple myeloma. The study will also explore preliminary proof-of-concept signals of deep responses and minimal residual disease (MRD) negativity with this regimen, thereby informing the design of a subsequent phase II clinical trial.
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 smoldering multiple myeloma, POEMS syndrome, amyloidosis, or plasma cell leukemia.
Presence of central nervous system involvement.
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.
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.
Single group
F182112 Plus Isatuximab and Lenalidomide
DrugInduction treatment phase: F182112: Administered by intravenous infusion. Patients will receive three step-up doses of F182112 at 3 μg/kg, 30 μg/kg, and 180 μg/kg on Days 1, 4, and 8 of Cycle 1, respectively, followed by intravenous administration of F182112 at 180 μg/kg once weekly. Isatuximab: Administered by intravenous infusion at 10 mg/kg. Patients will receive isatuximab on Days 1, 8, 15, and 22 of Cycle 1, and on Days 1 and 15 of each cycle from Cycle 2 to Cycle 6. Lenalidomide: Administered orally at 25 mg on Days 1-21 of each cycle. Maintenance treatment phase: F182112: Administered by intravenous infusion at 180 μg/kg once every 2 weeks. If sustained MRD negativity is maintained for more than 6 months after completion of induction treatment, the investigator may consider adjusting the subsequent dosing frequency to once every 4 weeks. Isatuximab: Administered by intravenous infusion at 10 mg/kg. During the maintenance treatment phase, isatuximab will be administered once
The incidence and outcomes of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) occurring from the initiation of the first study treatment through the end of Cycle 6, or through 30 days after premature discontinuation of study t
MRD negativity rate after 6 cycles (10-6)
MRD negativity rate after 6 cycles (10-5)
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