A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing F182112 with Standard of Care in Patients with Relapsed or Refractory Multiple Myeloma
Provide informed consent and voluntarily sign the informed consent form; Be male or female, aged ≥18 years;
Have relapsed or refractory multiple myeloma (RRMM) who have previously failed therapy with regimens containing at least one agent from each of the following three drug classes: proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies; i. Relapsed: Disease progression requiring salvage therapy after achieving a minimal response (MR) or better following prior anti-myeloma therapy; ii. Refractory: Lack of response (failure to achieve MR or better) during the last anti-myeloma therapy, or disease progression within 60 days after the last anti-myeloma therapy;
Before randomization, the investigator must pre-select a standard of care (SOC) treatment regimen based on the patient's disease status;
Have an ECOG performance status of 0-2;
Central nervous system involvement or clinical symptoms of meningeal involvement by multiple myeloma;
Concomitant light chain amyloidosis, plasma cell leukemia, Waldenström macroglobulinemia, or POEMS syndrome;
History of any other malignancy within 3 years prior to first dose, except for malignancies with very low recurrence risk after curative treatment (e.g., squamous cell carcinoma or basal cell carcinoma of the skin, in situ cervical or breast cancer), or those who have undergone curative surgical resection (or other treatment) with no current evidence of disease and unlikely to impact survival during the study period;
Dysphagia or active gastrointestinal dysfunction that may impair drug absorption;
Parallel
F182112 single-agent
DrugF182112 single-agent
Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)
DrugPomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)
the progression-free survival (PFS) evaluated by the Independent Review Committee (IRC) according to the 2016 IMWG criteria
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