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.
ASCENT (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.
LIGHTHOUSE (NCT04649060) is a randomized, controlled, open-label, Phase 3 multicenter study which is enrolling patients that have Relapsed Refractory Multiple Myeloma and are double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI. Patients will receive treatment of melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity or patient/treating physician decision. Patients in the daratumumab treatment arm will after confirmed progressive disease have the option to receive treatment with melflufen+dexamethasone+daratumumab.