Pomalidomide-based regimens
| Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Lacy et al, 200939 | 2 | 60 | Pd | P 2 mg/d on days 1-21 q 28 d, D 40 mg PO weekly | 2 | 63 | 33 | 11.6 | NR | NR | N 19%, L 10%, F 10% |
| Leleu et al, 201332 | 2 | 43 | Pd | P 4 mg/d on days 1-21 q 28 d, D 40 mg PO weekly | 5 | 35 | 4 | 5.4 | 14.9 | 22.8 | N 65%, A 37%, T 28%, I 19% |
| 41 | Pd | P 4 mg PO daily q 28 d, D 40 mg PO weekly | 5 | 34 | 7 | 3.7 | 14.8 | N 58.5%, A 34%, T 27%, I 27% | |||
| P | .45 | ||||||||||
| Richardson et al, 201431 | 2 | 113 | Pd | P 4 mg/d on days 1-21 q 28 d, D 40 mg PO weekly | 5 | 33 | NR | 4.2 | 16.5 | 14.2 | N 41%, A 22%, T 19%, L 10%, F 14% |
| 108 | P | P 4 mg/d on days 1-21 q 28 d | 5 | 18 | NR | 2.7 | 13.6 | N 48%, A 24%, T 22%, L 7%, F 11% | |||
| P | .013 | .003 | .709 | ||||||||
| San Miguel et al, 201333 | 3 | 302 | Pd | P 4 mg/d on days 1-21, D 40 mg/d on days 1, 8, 15, 22, PO | 5 | 31 | 6 | 4 | 12.7 | 10 | N 48%, A 33%, T 22%, F 5%, I 34% |
| 153 | D | D 40 mg/d on days 1-4, 9-12, 17-20, PO | 5 | 10 | <1 | 1.9 | 8.1 | N 16%, A 37%, T 26%, F 6%, I 33% | |||
| P | <.001 | <.0001 | .0285 | ||||||||
| Mark et al, 201337 | 2 | 119 | ClaPd | Cla 500 mg BID PO, P 4 mg days 1-21, D 40 mg weekly q 28 d | 5 | 61.4 | 16.7 | 8.1 | NR | 11.9 | N 49%, T 39%, A 27%, F 8%, DVT 5% |
| Richardson et al, 201340 | 2 | 28 | PVD | dose escalation of P from 1-4 mg/d, V from 1-1.3 mg/m2, and D 20 mg/d on days 1, 2, 4, 5, 8, 9, 11, 12 q 28 d | 2 | 70 | 43 | NR | NR | NR | N 39%, T 25% |
| Shah et al, 201335 | 1/2 | 72 | CPd | CFZ 20/27 mg/m2 IV on days 1, 2, 8, 9, 15, 16; P 4 mg on days 1-21; D 40 mg on days 1, 8, 15, 22 q 28 d | 6 | 64 | 26.3 | 12 | 16.3 | 6 | F 48%, N 40%, A 34%, T 34%, Di 20% |
| Berenson et al, 201341 | 1/2 | 33 | Pd+PLD | P dose escalation from 2-4 mg on days 1-21 of 28-d cycle, D 40 mg and PLD 5 mg/m2 IV on days 1, 4, 8, 11 | 5 | 34.5 | 5 | NR | 3.2 | N 58.8%, L 37.5%, A 9.4%, T 6.3%, 1 sepsis death | |
| Larocca et al, 201336 | 2 | 55 | PPr+Cy | P 2.5 mg/d, Cy 50 mg, Pr 50 mg qod q 28 d | 3 | 51 | 24 | 10.4 | NR | 14.8 | A 9%, T 11%, N 42%, TEE 2%, I 9% |
| Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Lacy et al, 200939 | 2 | 60 | Pd | P 2 mg/d on days 1-21 q 28 d, D 40 mg PO weekly | 2 | 63 | 33 | 11.6 | NR | NR | N 19%, L 10%, F 10% |
| Leleu et al, 201332 | 2 | 43 | Pd | P 4 mg/d on days 1-21 q 28 d, D 40 mg PO weekly | 5 | 35 | 4 | 5.4 | 14.9 | 22.8 | N 65%, A 37%, T 28%, I 19% |
| 41 | Pd | P 4 mg PO daily q 28 d, D 40 mg PO weekly | 5 | 34 | 7 | 3.7 | 14.8 | N 58.5%, A 34%, T 27%, I 27% | |||
| P | .45 | ||||||||||
| Richardson et al, 201431 | 2 | 113 | Pd | P 4 mg/d on days 1-21 q 28 d, D 40 mg PO weekly | 5 | 33 | NR | 4.2 | 16.5 | 14.2 | N 41%, A 22%, T 19%, L 10%, F 14% |
| 108 | P | P 4 mg/d on days 1-21 q 28 d | 5 | 18 | NR | 2.7 | 13.6 | N 48%, A 24%, T 22%, L 7%, F 11% | |||
| P | .013 | .003 | .709 | ||||||||
| San Miguel et al, 201333 | 3 | 302 | Pd | P 4 mg/d on days 1-21, D 40 mg/d on days 1, 8, 15, 22, PO | 5 | 31 | 6 | 4 | 12.7 | 10 | N 48%, A 33%, T 22%, F 5%, I 34% |
| 153 | D | D 40 mg/d on days 1-4, 9-12, 17-20, PO | 5 | 10 | <1 | 1.9 | 8.1 | N 16%, A 37%, T 26%, F 6%, I 33% | |||
| P | <.001 | <.0001 | .0285 | ||||||||
| Mark et al, 201337 | 2 | 119 | ClaPd | Cla 500 mg BID PO, P 4 mg days 1-21, D 40 mg weekly q 28 d | 5 | 61.4 | 16.7 | 8.1 | NR | 11.9 | N 49%, T 39%, A 27%, F 8%, DVT 5% |
| Richardson et al, 201340 | 2 | 28 | PVD | dose escalation of P from 1-4 mg/d, V from 1-1.3 mg/m2, and D 20 mg/d on days 1, 2, 4, 5, 8, 9, 11, 12 q 28 d | 2 | 70 | 43 | NR | NR | NR | N 39%, T 25% |
| Shah et al, 201335 | 1/2 | 72 | CPd | CFZ 20/27 mg/m2 IV on days 1, 2, 8, 9, 15, 16; P 4 mg on days 1-21; D 40 mg on days 1, 8, 15, 22 q 28 d | 6 | 64 | 26.3 | 12 | 16.3 | 6 | F 48%, N 40%, A 34%, T 34%, Di 20% |
| Berenson et al, 201341 | 1/2 | 33 | Pd+PLD | P dose escalation from 2-4 mg on days 1-21 of 28-d cycle, D 40 mg and PLD 5 mg/m2 IV on days 1, 4, 8, 11 | 5 | 34.5 | 5 | NR | 3.2 | N 58.8%, L 37.5%, A 9.4%, T 6.3%, 1 sepsis death | |
| Larocca et al, 201336 | 2 | 55 | PPr+Cy | P 2.5 mg/d, Cy 50 mg, Pr 50 mg qod q 28 d | 3 | 51 | 24 | 10.4 | NR | 14.8 | A 9%, T 11%, N 42%, TEE 2%, I 9% |
A, anemia; BID, twice daily; Cla, clarithromycin; CPd, carfilzomib, pomalidomide, and dexamethasone; Cy, cyclophosphamide; D, dexamethasone; Di, diarrhea; DVT, deep venous thrombosis; F, fevers; f/u, follow-up; G, grade; I, infections; IV, intravenous; L, lymphopenia; m, months; N, neutropenia; NR, not reported; OS, overall survival; P, pomalidomide; Pr, prednisone; Pd, pamolidomide and low-dose dexamethasone; PFS, progression-free survival; PLD, pegylated liposomal doxorubicin; PO, per os; PR, partial response; PVD, pomalidomide, bortezomib, and dexamethasone; qod, every other day; T, thrombocytopenia; TEE, thromboembolic events; TTP, time to progression; VGPR, very good partial response; yr, years.