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Phase II study of bendamustine, bortezomib and dexamethasone ( BBD ) in the first‐line treatment of patients with multiple myeloma who are not candidates for high dose chemotherapy
Author(s) -
Berdeja Jesus G.,
Bauer Todd,
Arrowsmith Edward,
Essell James,
Murphy Patrick,
Reeves James A.,
Boccia Ralph V.,
Donnellan William,
Flinn Ian
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.14536
Subject(s) - bendamustine , bortezomib , dexamethasone , regimen , medicine , multiple myeloma , adverse effect , neutropenia , gastroenterology , population , chemotherapy , rituximab , lymphoma , environmental health
Summary The combination of bendamustine, bortezomib and dexamethasone ( BBD ) was evaluated as a first‐line therapy for multiple myeloma. The original treatment regimen of bendamustine 80 mg/m 2 , days 1, 4; bortezomib 1·3 mg/m 2 , days 1, 4, 8, 11; dexamethasone 40 mg, days 1, 2, 3, 4 on a 28‐day cycle (up to 8 cycles) was efficacious but determined relatively toxic in an interim analysis. The regimen was amended to bendamustine 80 mg/m 2 , days 1, 2; bortezomib 1·3 mg/m 2 , days 1, 8, 15; dexamethasone 20 mg, days 1, 2, 8, 9, 15, 16 every 28 days (up to 8 cycles), then maintenance 1·3 mg/m 2 IV bortezomib every 2 weeks. Fifty‐nine patients were enrolled. Primary endpoint was complete response (CR) rate. The original schema was given for a median of 7 cycles (range 1–8); modified schema was given for a median of 8 cycles (range 1‐8) plus maintenance. Overall response was 91%, CR was 9%. Median follow‐up was 19·1 months; median progression‐free survival was 11·1 months and 18·9 months on the original and modified regimens, respectively. The most common Grade 3/4 adverse events were fatigue and neuropathy. The combination of BBD is tolerable and efficacious in this patient population. Modifications to decrease intensity but increase duration translated to better outcomes.