Cyclophosphamide Bortezomib Dexamethasone

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Standard Regimen

Bortezomib 1.3 mg/m(2) intravenously on days 1, 4, 8 and 11
Cyclophosphamide 300 mg/m(2) orally on days 1, 8, 15 and 22
Dexamethasone 40 mg orally on days 1-4, 9-12 and 17-20 on a 28-day cycle

Reference

Reeder CB et al Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial. Leukemia. 2009 Jul;23(7):1337-41. Epub 2009 Feb 19.
We have studied a three-drug combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) on a 28-day cycle in the treatment of newly diagnosed multiple myeloma (MM) patients to assess response and toxicity. The primary endpoint of response was evaluated after four cycles. Thirty-three newly diagnosed, symptomatic patients with MM received bortezomib 1.3 mg/m(2) intravenously on days 1, 4, 8 and 11, cyclophosphamide 300 mg/m(2) orally on days 1, 8, 15 and 22 and dexamethasone 40 mg orally on days 1-4, 9-12 and 17-20 on a 28-day cycle for four cycles. Responses were rapid with a mean 80% decline in the sentinel monoclonal protein at the end of two cycles. The overall intent to treat response rate (>or= partial response) was 88%, with 61% of very good partial response or better (>or=VGPR) and 39% of complete/near complete response (CR/nCR). For the 28 patients who completed all four cycles of therapy, the CR/nCR rate was 46% and VGPR rate was 71%. All patients undergoing stem cell harvest had a successful collection. Twenty-three patients underwent stem cell transplantation (SCT) and are evaluable through day 100 with CR/nCR documented in 70% and >or=VGPR in 74%. In conclusion, CyBorD produces a rapid and profound response in patients with newly diagnosed MM with manageable toxicity.

Weekly Regimen

Bortezomib 1.5 mg/m2 SC or IV Days 1, 8, 15, and 22
Cyclophosphamide 300 mg/m2 by mouth, once weekly Days 1, 8, 15, and 22
Dexamethasone	40 mg by mouth, once weekly Days 1, 8, 15, and 22

Reference

Reeder CB, et al. Blood 2010; 115:3416.Full text For those completing all 4 cycles of therapy (n = 55), the ORR is 95% with 47% CR/nCR and 67% VGPR or better. Patients in the once weekly bortezomib cohort achieved responses similar to the twice weekly cohort (ORR 93% vs 88%, ≥ VGPR 60% vs 61%) and experienced less grade 3/4 adverse events (37%/3% vs 48%/12%). Fewer dose reductions of bortezomib and dexamethasone were required in the modified schedule and neuropathy rates were the same in both cohorts even though the total bortezomib dose per cycle was higher in the weekly versus the twice weekly schedule (6.0 mg/m2 vs 5.2/mg/m2).