Bortezomib-based regimens
| Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Richardson et al, 200342 | 2 | 202 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 28 d | 6 | 27 | 10 | 7 | 16 | NR | T 28%, F 12%, PN 12%, N 11% |
| Richardson et al, 200549 | 3 | 333 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d | 2 | 38 | 7 | 6.2 | 29.8 | 22 | N 14%, A 10%, T 30%, PN 8% |
| 336 | D | D 40 mg on days 1-4, 9-12, 17-20 q 35 d | 2 | 18 | 1 | 3.5 | 23.7 | N 1%, A 11%, T 6%, PN 1% | |||
| P | <.001 | <.001 | <.001 | .0027 | |||||||
| Orlowski et al, 200746 | 3 | 324 | V-PLD | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; T 200 mg PO daily; D 40 mg weekly | ≥2 | 44 | 27 | 9.3 | 76% | 7.2 | N 29%, A 9%, T 23%, PN 3% |
| 322 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d | ≥2 | 41 | 19 | 6.5 | 65% | N 15%, A 9%, T 16%, PN 5% | |||
| P | .43 | .015 | .000004 | .03 | 15 m OS | ||||||
| Garderet et al, 20126 | 3 | 135 | VTD | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; T 200 mg daily; D 40 mg weekly | 87 | 56 | 18.3 | 71% | 30 | N 11%, A 8%, T 17%, PN 31%, I 14% | |
| 134 | TD | T 200 mg daily, D 40 mg weekly | 72 | 35 | 13.6 | 65% | N 16%, A 5%, T 7%, PN 14%, I 7% | ||||
| P | <.001 | <.001 | .001 | .09 | 2 y OS | ||||||
| Dimopoulos et al, 201350 | 3 | 317 | V+Vorinostat | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; Vorinostat 400 mg PO on days 1-14 | 2 | 56.2 | 7.63 | NR | 14.2 | N 29%, A 17%, T 45%, Di 16%, F 16% | |
| 320 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d | 2 | 40.6 | 6.83 | 28.07 | N 25%, A 13%, T 24%, Di 9%, F 5% | ||||
| P | <.0001 | .01 | |||||||||
| Richardson et al, 201348 | 2 | 55 | VD+Panobinostat | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; Panobinostat 20 mg PO 3 times per week | 4 | 34.5 | 5.4 | NR | T 64%, Di 20%, F 20% | ||
| Orlowski et al, 2012129 | 2 | 142 | V+Siltuximab | V 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, 32 q 42 d; Siltuximab 6 mg/kg IV q2w | 55 | 11 | 8.1 | 30.8 | 24.5 | N 49%, T 48%, A 11%, I 16% | |
| 144 | V | V 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, 32 q 42 d | 47 | 7 | 7.6 | 36.9 | N 30%, T 34%, A 15%, I 14% | ||||
| P | .213 | .342 | .345 | .103 | |||||||
| Offidani et al, 201344 | 2 | 75 | VD+Bendamustine | V 1.3 mg/m2 on days 1, 4, 8, 11; B 70 mg/m2 IV on days 1 and 8 q 21 d | 4 | 71.5 | 34.5 | 16.5 | 78% | 12 | N 18.5%, T 30.5%, I 12%, PN 8% |
| Reece et al, 201419 | 1 | 98 | VCyP | V 1.5 mg/m2 weekly, Cy 300 mg/m2, P 100 mg PO qod | 2 | 68 | 42 | 15% 1 y PFS | 89% 1 y OS | 17 | N 13%, T 70%, I 13%, PN 8% |
| Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Richardson et al, 200342 | 2 | 202 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 28 d | 6 | 27 | 10 | 7 | 16 | NR | T 28%, F 12%, PN 12%, N 11% |
| Richardson et al, 200549 | 3 | 333 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d | 2 | 38 | 7 | 6.2 | 29.8 | 22 | N 14%, A 10%, T 30%, PN 8% |
| 336 | D | D 40 mg on days 1-4, 9-12, 17-20 q 35 d | 2 | 18 | 1 | 3.5 | 23.7 | N 1%, A 11%, T 6%, PN 1% | |||
| P | <.001 | <.001 | <.001 | .0027 | |||||||
| Orlowski et al, 200746 | 3 | 324 | V-PLD | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; T 200 mg PO daily; D 40 mg weekly | ≥2 | 44 | 27 | 9.3 | 76% | 7.2 | N 29%, A 9%, T 23%, PN 3% |
| 322 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d | ≥2 | 41 | 19 | 6.5 | 65% | N 15%, A 9%, T 16%, PN 5% | |||
| P | .43 | .015 | .000004 | .03 | 15 m OS | ||||||
| Garderet et al, 20126 | 3 | 135 | VTD | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; T 200 mg daily; D 40 mg weekly | 87 | 56 | 18.3 | 71% | 30 | N 11%, A 8%, T 17%, PN 31%, I 14% | |
| 134 | TD | T 200 mg daily, D 40 mg weekly | 72 | 35 | 13.6 | 65% | N 16%, A 5%, T 7%, PN 14%, I 7% | ||||
| P | <.001 | <.001 | .001 | .09 | 2 y OS | ||||||
| Dimopoulos et al, 201350 | 3 | 317 | V+Vorinostat | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; Vorinostat 400 mg PO on days 1-14 | 2 | 56.2 | 7.63 | NR | 14.2 | N 29%, A 17%, T 45%, Di 16%, F 16% | |
| 320 | V | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d | 2 | 40.6 | 6.83 | 28.07 | N 25%, A 13%, T 24%, Di 9%, F 5% | ||||
| P | <.0001 | .01 | |||||||||
| Richardson et al, 201348 | 2 | 55 | VD+Panobinostat | V 1.3 mg/m2 on days 1, 4, 8, 11 q 21 d; Panobinostat 20 mg PO 3 times per week | 4 | 34.5 | 5.4 | NR | T 64%, Di 20%, F 20% | ||
| Orlowski et al, 2012129 | 2 | 142 | V+Siltuximab | V 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, 32 q 42 d; Siltuximab 6 mg/kg IV q2w | 55 | 11 | 8.1 | 30.8 | 24.5 | N 49%, T 48%, A 11%, I 16% | |
| 144 | V | V 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, 32 q 42 d | 47 | 7 | 7.6 | 36.9 | N 30%, T 34%, A 15%, I 14% | ||||
| P | .213 | .342 | .345 | .103 | |||||||
| Offidani et al, 201344 | 2 | 75 | VD+Bendamustine | V 1.3 mg/m2 on days 1, 4, 8, 11; B 70 mg/m2 IV on days 1 and 8 q 21 d | 4 | 71.5 | 34.5 | 16.5 | 78% | 12 | N 18.5%, T 30.5%, I 12%, PN 8% |
| Reece et al, 201419 | 1 | 98 | VCyP | V 1.5 mg/m2 weekly, Cy 300 mg/m2, P 100 mg PO qod | 2 | 68 | 42 | 15% 1 y PFS | 89% 1 y OS | 17 | N 13%, T 70%, I 13%, PN 8% |
A, anemia; Cy, cyclophosphamide; Di, diarrhea; F, fevers; f/u, follow-up; G, grade; I, infections; IV, intravenous; m, months; TD, thalidomide and dexamethasone; N, neutropenia; NR, not reported; OS, overall survival; P, prednisone; PFS, progression-free survival; PLD, pegylated liposomal doxorubicin; PO, per os; PR, partial response; qod, every other day; SC, subcutaneous; T, thrombocytopenia; TTP, time to progression; V, bortezomib; VD, bortezomib and dexamethasone; VGPR, very good partial response; yr, years.