Thalidomide-based regimens
| Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Singhal et al, 19994 | 1 | 84 | THAL | THAL escalation from 200 mg to 800 mg PO | 24 | 9 | 21.4% | 60.7% | 12 | C 35%, S 34%, PN 12% (all grades for 200-mg dosing) | |
| Dimopoulos et al, 20013 | 2 | 44 | TD | THAL 200 mg, D 20 mg/m2 on days 1-4, 9-12, 17-20, orally followed by monthly D × 4 d | 3 | 55 | 4.2 | 12 | NR | C 75, S 57%, PN 23% (all grades) | |
| Kropff et al, 200310 | 2 | 60 | CyTD | HC 300 mg/m2 IV q 12 h × 6 on days 1-3, D 20 mg/m2 daily on days 1-4, 9-12, 17-20, T 100-400 mg/d PO | 2 | 72 | 11 | 19 | NR | N 67%, PN 16%, C 17%, DVT 8%, CVA 5% | |
| Dimopoulos et al, 20049 | 2 | 53 | CyTD | Cy 150 mg/m2 q 12 h PO days 1-5, THAL 400 mg PO days 1-5, 14-18, D 20 mg/m2 PO days 1-5, 14-18 | 60 | 12 (TTP) | 17.5 | NR | DVT 4%, PN 2% | ||
| Palumbo et al, 200611 | 1/2 | 24 | MPT | M 20 mg/m2 on day 1, THAL 50-100 mg/d PO, P 50 mg/d qod | 3 | 41 | 9 | 14 | NR | A 32%, N 33%, T 12% | |
| Offidani et al, 200712 | 47 | TD-PLD | THAL 100 mg, PLD 40 mg/m2 on day 1, D 40 mg PO on days 1-4, 9-12 every 28 days | 3 | 75.5 | 36 | 21 | 35.5 | 27 | N 25%, PN 2%, T 7%, I 23%, TEE 13% | |
| 47 | TD | THAL 100 mg, D 40 mg PO on days 1-4, 9-12 every 28 days | 3 | 59.5 | 15 | 11.5 | 20 | Confusion 2%, TEE 6% Cardiotoxicity 6% | |||
| P | .077 | .018 | .0087 | .012 | |||||||
| Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Singhal et al, 19994 | 1 | 84 | THAL | THAL escalation from 200 mg to 800 mg PO | 24 | 9 | 21.4% | 60.7% | 12 | C 35%, S 34%, PN 12% (all grades for 200-mg dosing) | |
| Dimopoulos et al, 20013 | 2 | 44 | TD | THAL 200 mg, D 20 mg/m2 on days 1-4, 9-12, 17-20, orally followed by monthly D × 4 d | 3 | 55 | 4.2 | 12 | NR | C 75, S 57%, PN 23% (all grades) | |
| Kropff et al, 200310 | 2 | 60 | CyTD | HC 300 mg/m2 IV q 12 h × 6 on days 1-3, D 20 mg/m2 daily on days 1-4, 9-12, 17-20, T 100-400 mg/d PO | 2 | 72 | 11 | 19 | NR | N 67%, PN 16%, C 17%, DVT 8%, CVA 5% | |
| Dimopoulos et al, 20049 | 2 | 53 | CyTD | Cy 150 mg/m2 q 12 h PO days 1-5, THAL 400 mg PO days 1-5, 14-18, D 20 mg/m2 PO days 1-5, 14-18 | 60 | 12 (TTP) | 17.5 | NR | DVT 4%, PN 2% | ||
| Palumbo et al, 200611 | 1/2 | 24 | MPT | M 20 mg/m2 on day 1, THAL 50-100 mg/d PO, P 50 mg/d qod | 3 | 41 | 9 | 14 | NR | A 32%, N 33%, T 12% | |
| Offidani et al, 200712 | 47 | TD-PLD | THAL 100 mg, PLD 40 mg/m2 on day 1, D 40 mg PO on days 1-4, 9-12 every 28 days | 3 | 75.5 | 36 | 21 | 35.5 | 27 | N 25%, PN 2%, T 7%, I 23%, TEE 13% | |
| 47 | TD | THAL 100 mg, D 40 mg PO on days 1-4, 9-12 every 28 days | 3 | 59.5 | 15 | 11.5 | 20 | Confusion 2%, TEE 6% Cardiotoxicity 6% | |||
| P | .077 | .018 | .0087 | .012 | |||||||
A, anemia; C, constipation; CVA, cerebrovascular accident; Cy, cyclophosphamide; DVT, deep venous thrombosis; f/u, follow-up; G, grade; HC, hyperfractionated cyclophosphamide; I, infections; IV, intravenous; m, months; MPT, melphalan, prednisone, and thalidomide; N, neutropenia; NR, not reported OS, overall survival; PFS, progression-free survival; PLD, pegylated liposomal doxorubicin; PN, peripheral neuropathy; PO, per os; PR, partial response; qod, every other day; S, somnolence; SC, subcutaneous; T, thrombocytopenia; TD, thalidomide and dexamethasone; TEE, thromboembolic events; THAL, thalidomide; TTP, time to progression; VGPR, very good partial response; yr, years.