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    Bendamustine, thalidomide and dexamethasone combination therapy for relapsed/refractory myeloma patients: results of the MUKone randomized dose selection trial.

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    Authors
    Schey, S
    Brown, S
    Tillotson, A
    Yong, K
    Williams, C
    Davies, F
    Morgan, G
    Cavenagh, J
    Cook, G
    Cook, M
    Orti, G
    Morris, C
    Sherratt, D
    Flanagan, L
    Gregory, W
    Cavet, James
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    Affiliation
    Department of Haematology, King's College Hospital, London
    Issue Date
    2015-08
    
    Metadata
    Show full item record
    Abstract
    There is a significant unmet need in effective therapy for relapsed myeloma patients once they become refractory to bortezomib and lenalidomide. While data from the front line setting suggest bendamustine is superior to melphalan, there is no information defining optimal bendamustine dose in multiply-treated patients. We report a multi-centre randomized two-stage phase 2 trial simultaneously assessing deliverability and activity of two doses of bendamustine (60 mg/m2 vs. 100 mg/m2) days 1 and 8, thalidomide (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 on trial, with a median three prior treatment lines. A pre-planned interim deliverability and activity assessment led to closure of the 100 mg/m2 arm due to excess cytopenias, and led to amendment of entry criteria for cytopenias. Non-haematological toxicities including thromboembolism and neurotoxicity were infrequent. In the 60 mg/m2 arm, treatment was deliverable in 61.1% subjects and the partial response rate was 46.3% in the study eligible population, with 7.5 months progression-free survival. This study demonstrates bendamustine at 60 mg/m2 twice per month with thalidomide and dexamethasone is deliverable for repeated cycles in heavily pre-treated myeloma patients and has substantial clinical activity.
    Citation
    Bendamustine, thalidomide and dexamethasone combination therapy for relapsed/refractory myeloma patients: results of the MUKone randomized dose selection trial. 2015, 170 (3):336-48 Br J Haematol
    Journal
    British Journal of Haematology
    URI
    http://hdl.handle.net/10541/578698
    DOI
    10.1111/bjh.13435
    PubMed ID
    25891006
    Type
    Article
    Language
    en
    ISSN
    1365-2141
    ae974a485f413a2113503eed53cd6c53
    10.1111/bjh.13435
    Scopus Count
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    All Christie Publications

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