Our Clinical Studies

Our Clinical Studies

Our clinical development program was created with the goal of providing a comprehensive set of data about melphalan flufenamide (also referred to as melflufen) in various patient groups. Please see below for more information on our studies or visit clinicaltrials.gov:

  • O-12-M1 (NCT01897714) is a single-arm, open-label, multicenter phase 1/2 study of melphalan flufenamide plus dexamethasone in patients with relapsed refractory multiple myeloma (RRMM)
  • HORIZON (NCT02963493) is a pivotal, single-arm, open-label, multicenter phase 2 study of melphalan flufenamide plus dexamethasone in heavily treated and poor-risk patients with RRMM.
  • OCEAN (NCT03151811) is a confirmatory, randomized, controlled, open-label direct comparison phase 3 study of melphalan flufenamide plus dexamethasone versus pomalidomide plus dexamethasone in patients with RRMM refractory to lenalidomide.
  • ANCHOR (NCT03481556) is a non-randomized, open label, phase 1/2 study evaluating melphalan flufenamide plus dexamethasone in combination with either bortezomib or daratumumab in patients with RRMM.
  • BRIDGE (NCT03639610) is an open-label pharmacokinetic phase 2 study of melphalan flufenamide plus dexamethasone in patients with RRMM and impaired renal function.
  • AL Amyloidosis (NCT04115956) is a phase 1/2 study evaluating melphalan flufenamide in patients with immunoglobulin light-chain (AL) amyloidosis. This is Oncopeptides’ first study outside multiple myeloma.
  • PORT (NCT04412707) is a randomized, two-period, crossover phase 2 study comparing PK, and assessing safety and tolerability and efficacy of peripheral and central infusion of melphalan flufenamide in patients with RRMM.

We have also planned an additional pivotal combination study LIGHTHOUSE.

Melphalan flufenamide is an investigational drug and has not been approved by the FDA or any other regulatory agency.