Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077)

摘要

Abstract Introduction While lenalidomide monotherapy is established for relapsed and/or refractory multiple myeloma (MM) treatment, combination therapies including lenalidomide are still under investigation in a number of phase 2/3 studies. In the current study, a treatment regime of lenalidomide (Revlimid ? ), bendamustine and prednisolone (RBP) was tested in patients with relapsed/refractory MM. Methods In the previously completed phase 1 study RBP with a dose of 75 mg/m 2 bendamustine days 1–2, prednisolone 100?mg days 1–4 and 25?mg lenalidomide days 1–21 was well tolerated. Results Between July 2011 and September 2013, 25 patients were included in this analysis. The median number of previous treatments was 1 (range 1–2). Twenty-two patients (88%) responded after at least two cycles of RBP (one sCR, five nCR, eight VGPR and eight PR). The median time to first haematological response was 28?days, and median time to best response was 56?days. Due to increased haematological toxicity a dose reduction in most patients required in subsequent cycles of therapy. The median progression-free and overall survival was 22 and 38?months, respectively. Summary In conclusion RBP is a highly effective therapy for patients with relapsed/refractory MM. In contrast to our phase 1 study, dose reduction was necessary in many patients because of haematological toxicity.