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Bendamustine, lenalidomide and dexamethasone (BRd) has high activity as 2 nd ‐line therapy for relapsed and refractory multiple myeloma – a phase II trial
Author(s) -
Mey Ulrich J. M.,
Brugger Wolfram,
Schwarb Heike,
Pederiva Stefanie,
Schwarzer Andreas,
Dechow Tobias,
Jehner Paul,
Rauh Jacqueline,
Taverna Christian J.,
Schmid Mathias,
SchmidtHieber Martin,
Doerfel Steffen,
Fischer Natalie,
Ruefer Axel,
Ziske Carsten,
Knauf Wolfgang,
Cathomas Richard,
Moos Roger,
Hitz Felicitas,
Sauter Rafael,
Hiendlmeyer Elke,
Cantoni Nathan,
Bargetzi Mario,
Driessen Christoph
Publication year - 2017
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.14481
Subject(s) - bendamustine , lenalidomide , medicine , dexamethasone , multiple myeloma , refractory (planetary science) , oncology , materials science , lymphoma , rituximab , composite material
Summary The combination of lenalidomide (Revlimid ® , R) and dexamethasone (d) is a standard regimen for patients with relapsed/refractory multiple myeloma (rr MM ). With this regimen, only a small fraction of patients will achieve high quality responses [≥ very good partial response ( VGPR )]. The combination of bendamustine (B), lenalidomide and dexamethasone ( BR d) has shown high efficacy in patients with advanced rr MM . However, dose‐limiting haematotoxicity restricted its use in extensively pre‐treated patient populations. This prospective, multicentre Phase II study evaluated the efficacy and safety of BR d in rr MM patients with one prior line of therapy. Fifty patients were enrolled (median age 68·5 years [range 46–83]) and were treated with B 75 mg/m 2 days 1, 2; R 25 mg days 1–21 and d (40/20 mg) days 1, 8, 15 and 22, for 6 28‐day induction cycles, followed by 12 cycles with Rd alone. Pegfilgrastim was administered according to protocol‐defined criteria. The study aimed to demonstrate a complete response ( CR )/ VGPR rate of >40% after induction therapy. Of 45 evaluable patients, 23 (51%) achieved a CR / VGPR . Grade 4 neutropenia or thrombocytopenia occurred in 17 (34%) and 8 (16%) of patients, respectively. BR d is a safe and efficacious regimen as a second line treatment for rr MM , leading to high quality responses in a considerable proportion of patients.