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.
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/m2, days 1, 4; bortezomib 1·3 mg/m2, 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/m2, days 1, 2; bortezomib 1·3 mg/m2, 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/m2IV 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.
Sarah Cannon Research Institute, Nashville, TN, USA.|Tennessee Oncology PLLC, Nashville, TN, USA.
Jesus G
JG
Berdeja
Sarah Cannon Research Institute, Nashville, TN, USA.|Tennessee Oncology PLLC, Nashville, TN, USA.
Todd
T
Bauer
Sarah Cannon Research Institute, Nashville, TN, USA.|Tennessee Oncology PLLC, Chattanooga, TN, USA.
Edward
E
Arrowsmith
Sarah Cannon Research Institute, Nashville, TN, USA.|Oncology Hematology Care, Inc, Cincinnati, OH, USA.
James
J
Essell
Sarah Cannon Research Institute, Nashville, TN, USA.|Tennessee Oncology PLLC, Nashville, TN, USA.
Patrick
P
Murphy
Sarah Cannon Research Institute, Nashville, TN, USA.|Florida Cancer Specialists, Ft. Myers, FL, USA.
James A
JA
Reeves
Center for Cancer and Blood Disorders, Bethesda, MD, USA.
Ralph V
RV
Boccia
Sarah Cannon Research Institute, Nashville, TN, USA.|Tennessee Oncology PLLC, Nashville, TN, USA.
William
W
Donnellan
Sarah Cannon Research Institute, Nashville, TN, USA.|Tennessee Oncology PLLC, Nashville, TN, USA.
Ian
I
Flinn
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage; D000069286:Bortezomib / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology
D000069286:Bortezomib; D003907:Dexamethasone; D000069461:Bendamustine Hydrochloride
bendamustine; bortezomib; dexamethasone; first-line treatment; multiple myeloma