Phase II trial to investigate efficacy and safety of bendamustine, dexamethasone and thalidomide in relapsed or refractory multiple myeloma patients after treatment with lenalidomide and bortezomib

In the last decade several reports regarding the administration of bendamustine in relapsed/refractory multiple myeloma have been published in this journal (Ponisch et al, 2008; Ramasamy et al, 2011; Grey-Davies et al, 2012). The last one was the two-step phase II trial MUKone (Schey et al, 2015), which evaluated the deliverability and activity of two doses of bendamustine (60 mg/m2 vs. 100 mg/m2 ) days 1 and 8, thalidomide (100 mg) days 1–21 and low dose dexamethasone (20 mg) days 1, 8, 15 and 22 of a 28-day cycle. In 2013, based on these positive experiences, we designed a phase II trial (EudraCT #: 2011-001775-39) to determine the efficacy and feasibility of the combination of bendamustine, dexamethasone and thalidomide, as these had not been evaluated prospectively at that time. Treatment consisted of intravenously administered bendamustine at a dose of 60 mg/m2 on days 1, 8 and 15, dexamethasone 20 mg per os on days 1, 8, 15 and 22 and thalidomide 100 mg daily per os on days 1–28 at an initial dose of 50 mg/day, with an increment to 100 mg after the first 15 days of treatment, repeated every 28 days for four to six cycles (BDT). Thrombosis prophylaxis was mandatory.