Phase III Study Comparing F182112 and Standard Treatments in Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the efficacy and safety of a drug called F182112 compared to standard treatments in patients with relapsed or refractory multiple myeloma RRMM. This phase III clinical trial focuses on patients who have not responded to previous therapies containing proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. The main goal is to assess progression-free survival PFS as defined by established criteria from the International Myeloma Working Group IMWG in 2016. Participants will be randomly assigned to receive either F182112 alone or one of the standard treatment combinations Pomalidomide with Bortezomib and Dexamethasone PVd or Selinexor with Bortezomib and Dexamethasone SVd. Before randomization, investigators will select the appropriate standard care regimen based on the patients disease status. The study is open-label, meaning both patients and researchers know which treatment is given. During the trial, participants will be closely monitored with regular clinical evaluations to measure disease progression and organ function. Researchers will assess blood and urine markers to track myeloma activity and safety. The primary outcome, progression-free survival, will be evaluated over a two-year period by an independent committee. The total study duration and follow-up will span several years, ensuring thorough safety and efficacy assessments throughout the trial.

A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma