Treatment arms and dose modifications for toxicity
| . | Bortezomib 1.3 mg/m2, days 1, 4, 8, 11 . | Dexamethasone 40 mg, days 1, 8, 15 . | Cyclophosphamide 500 mg/m2,* days 1, 8 . | Lenalidomide, days 1-14 . |
|---|---|---|---|---|
| First-dose reduction | 1.0 mg/m2 days 1, 4, 8, 11 | 20 mg days 1, 8, 15 | 400 mg/m2 days 1, 8 (15**) | 20 mg† days 1-14 |
| Second-dose reduction | 0.7 mg/m2 days 1, 4, 8, 11 | 8 mg days 1, 8, 15 | 300 mg/m2 days 1, 8 (15**) | 15 mg† days 1-14 |
| Third-dose reduction | Discontinue | Discontinue | 200 mg/m2 days 1, 8 (15**) | 10 mg† days 1-14 |
| Fourth-dose reduction | 100 mg/m2 days 1, 8 (15**) | 5 mg† days 1-14 | ||
| Fifth-dose reduction | Discontinue | Discontinue |
| . | Bortezomib 1.3 mg/m2, days 1, 4, 8, 11 . | Dexamethasone 40 mg, days 1, 8, 15 . | Cyclophosphamide 500 mg/m2,* days 1, 8 . | Lenalidomide, days 1-14 . |
|---|---|---|---|---|
| First-dose reduction | 1.0 mg/m2 days 1, 4, 8, 11 | 20 mg days 1, 8, 15 | 400 mg/m2 days 1, 8 (15**) | 20 mg† days 1-14 |
| Second-dose reduction | 0.7 mg/m2 days 1, 4, 8, 11 | 8 mg days 1, 8, 15 | 300 mg/m2 days 1, 8 (15**) | 15 mg† days 1-14 |
| Third-dose reduction | Discontinue | Discontinue | 200 mg/m2 days 1, 8 (15**) | 10 mg† days 1-14 |
| Fourth-dose reduction | 100 mg/m2 days 1, 8 (15**) | 5 mg† days 1-14 | ||
| Fifth-dose reduction | Discontinue | Discontinue |
V indicates bortezomib; D, dexamethasone; R, lenalidomide; C, cyclophosphamide; and VDC-mod, VDC plus a day 15 dose of C.
Cyclophosphamide was given as a single oral dose, rounded to the nearest 50 mg.
Day 15 only for VDC-mod arm.
Values shown for VDR arm; in the VDCR arm, lenalidomide dose reductions were 10, 5, and discontinue.