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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
Authors: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
Affiliation:1. Department of Haematology and Oncology, University of Leipzig, , Leipzig, Germany;2. Department of Haematology and Oncology, Hospital Johanniter Krankenhaus, , Stendal, Germany;3. Haematology Practice, , D?sen, Leipzig, Germany;4. Haematology Practice, , Halle (Saale), Germany;5. Department of Haematology and Oncology, Hospital Johann Kentmann, , Torgau, Germany;6. Department of Haematology and Oncology, Paul Gerhardt Stift, , Wittenberg, Germany;7. Haematology Practice, , Schkeuditz, Germany
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/m2/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/m2. 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/m2 and another patient at the highest dose level (lenalidomide 25 mg/d and bendamustine 75 mg/m2). 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/m2 days 1–2 is well tolerated in patients with relapsed/refractory MM.
Keywords:relapsed/refractory multiple myeloma  lenalidomide  bendamustine  prednisolone  phase 1 study
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