Schey, S, Brown, SR, Tillotson, A-L et al. (13 more authors) (2015) Bendamustine, thalidomide and dexamethasone combinationtherapy for relapsed/refractory myeloma patients: results ofthe MUKone randomized dose selection trial. British Journal of Haematology, 170 (3). pp. 336-348. ISSN 0007-1048
Abstract
There is a signific ant unmet need in effective therapy for relapsed myelomapatients once they become refractory to bortezomib and lenalidomide.While data from the front line setting suggest bendamustine is superior tomelphalan , there is no information defining op timal bendamustine dose inmultiply-treated patients. We report a multi-centre randomized two-stagephase 2 trial simultaneously assessing deliverability and activity of twodoses of bendamustine (60 mg/m2vs. 100 mg/m2) days 1 and 8, thalido -mide (100 mg) days 1–21 and low dose dexamethasone (20 mg) days 1, 8,15 and 22 of a 28-d cycle. Ninety-four relapsing patients were treated ontrial, with a median three prior treatment lines. A pre-planned interimdeliverability and activity assessm ent led to closure of the 100 mg/m2armdue to excess cytopenias, and led to amendment of entry criteria for cy-topenias. Non-haematolo gical toxicities including thromboembolism andneurotoxicity were infrequent. In the 60 mg/m2arm, treatment was deliver-able in 611% subjects and the partial response rate was 463% in the studyeligible population, with 75 months progression-free survival. This studydemonstrates bendamustine at 60 mg/m2twice per month with thalido-mide and dexamethasone is deliverable for repeated cycles in heavily pre-treated myeloma patients and has substantial clinical activity.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Keywords: | myeloma; dosing; phase 2; bendamustine; relapsed-refractory |
Dates: |
|
Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds) > Section of Oncology and Clinical Research (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Clinical Trials Research (LICTR) (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 05 Jul 2016 15:21 |
Last Modified: | 03 Nov 2016 18:57 |
Published Version: | http://dx.doi.org/10.1111/bjh.13435 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.1111/bjh.13435 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:94309 |