Rationale and study design
O-12-M1 was an international, multicenter, open-label phase 1/2 study to establish the dose of melflufen in combination with dexamethasone and investigate the treatment response in patients with relapsed refractory multiple myeloma, who were refractory to the last line of therapy.
The phase 2 study included 45 relapsed refractory multiple myeloma patients who were heavily pre-treated. They received a median of 4 prior lines of therapy and were refractory to lenalidomide (immunomodulatory imid drug, IMiD) and bortezomib (proteasome inhibitor, PI). Oncopeptides completed the enrollment of patients in late 2016 and presented final results in 2017.