Investigators and Patients should be aware that there is a partial clinical hold in place for Oncopeptides’ Clinical Trials, which means that we are not currently enrolling new patients. If patients are receiving a clinical benefit from melphalan flufenamide they may continue treatment provided they are informed of the risks and sign a revised written informed consent.
Further HCPSs and patient should note that on July 28, the US Food and Drug Administration issued a safety alert regarding an increased risk of death associated with Pepaxto® (melphalan flufenamide), in the OCEAN study. To read this alert you may visit the FDA website here.
Patient safety is paramount to Oncopeptides. We are fully cooperating with the FDA as they continue to evaluate the OCEAN data. We will provide additional updates as they become available.
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.