Lenalidomide, bendamustine and prednisolone exhibits a favourable safety and efficacy profile in relapsed or refractory multiple myeloma: final results of a phase 1 clinical trial OSHO - #077
Wolfram Pönisch, Simone Heyn, Juliane Beck, Ina Wagner, Martin Mohren, Franz A Hoffmann, Thoralf Lange, Marion Schmalfeld, Thomas Zehrfeld, Andreas Schwarzer, Cornelia Winkelmann, Thomas Edelmann, Ramona Röhrborn, Karin Hebenstreit, Haifa K Al-Ali, Nadja Jäkel, Dietger Niederwieser, Wolfram Pönisch, Simone Heyn, Juliane Beck, Ina Wagner, Martin Mohren, Franz A Hoffmann, Thoralf Lange, Marion Schmalfeld, Thomas Zehrfeld, Andreas Schwarzer, Cornelia Winkelmann, Thomas Edelmann, Ramona Röhrborn, Karin Hebenstreit, Haifa K Al-Ali, Nadja Jäkel, Dietger Niederwieser
Abstract
This phase 1 dose finding study tested a combination of lenalidomide, bendamustine and prednisolone (RBP) in 21 patients in five cohorts with advanced multiple relasped/refractory myeloma (MM) to determine the maximum tolerable dose (MTD) of the combination. The first cohort received a starting dose of lenalidomide 10 mg/d, days 1-21, bendamustine 60 mg/m(2) /d, days 1-2, and prednisolone 100 mg/d, days 1-4. Dose escalation was done in cohorts of three to six patients with lenalidomide dose increasing to 15, 20 and 25 mg, and after reaching 25 mg/d, bendamustine was increased to 75 mg/m(2) . A total of 21 patients were enrolled and all completed at least two cycles. Two patients developed dose-limiting haemotoxicity: one patient on lenalidomide 25 mg/d and bendamustine 60 mg/m(2) and another patient at the highest dose level (lenalidomide 25 mg/d and bendamustine 75 mg/m(2) ). The MTD was not reached. Sixteen patients (76%) responded after at least two cycles of RBP with one stringent complete response (CR), one near CR, five very good partial response and nine partial response. After a median observation time of 16 months, progression-free survival at 18 months was 48% and overall survival was 64%. In conclusion, RBP with lenalidomide 25 mg/d, days 1-21 and bendamustine 75 mg/m(2) days 1-2 is well tolerated in patients with relapsed/refractory MM.
Keywords: bendamustine; lenalidomide; phase 1 study; prednisolone; relapsed/refractory multiple myeloma.
© 2013 John Wiley & Sons Ltd.
Source: PubMed