OCEAN (R/R)

A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide

Study treatments

• Experimental arm: Melflufen 40 mg intravenous on Day 1 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle
• Standard arm: Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle

Inclusion criteria

• Age ≥ 18 years
• A prior diagnosis of multiple myeloma with documented disease progression
• Measurable disease defined as any of the following:
  • Serum monoclonal protein ≥ 0.5 g/dL by protein electrophoresis
  • ≥ 200 mg/24 hours of monoclonal protein in the urine on 24-hour electrophoresis
  • Serum free light chain ≥ 10 mg/dL AND abnormal serum kappa to lambda free light chain ratio
• Received 2-4 prior lines of therapy, including lenalidomide and a PI, either sequential or in the same line, and is refractory (relapsed and refractory or refractory) to both the last line of therapy and to lenalidomide (≥ 10 mg) administered within 18 months prior to randomization. 
• Must be able to take antithrombotic prophylaxis
• Must have, or be willing to have an acceptable central catheter

Exclusion criteria

• Primary refractory disease (i.e. never responded (≥ MR) to any prior therapy)
• Prior exposure to pomalidomide
• Known intolerance to IMiDs
• Prior peripheral stem cell transplant within 12 weeks of randomization

Participating sites

• UZ Antwerpen