Table 2.
Thalidomide in upfront therapy symptomatic MM patients not candidates for high dose chemotherapy (HDT)
| Trial | Regimen | Thalidomide dose (mg/day) | Duration | No.of patients | Response (EBMT criteria) | Survival |
|---|---|---|---|---|---|---|
| Phase II (Dingli et al 2005) | TD (1) | 200 | Until PD | 21 | PR + MR 48% | Median PFS 18 months |
| Phase II (Dimopoulos et al 2006) | TDM (2) | 300 | 3 cycles* | 50 | PR + CR 72% | Median time to progres sion 21.2 months |
| Phase II (Palumbo et al 2005) | MPT (3) | 100 | 6 cycles# | 41 | PR + CR 73% | Median EFS 30 months |
| Phase III (Palumbo et al 2006) | MPT v MP (3) | 100 | 6 cycles# | 255 | PR + CR 76% v 47.6% | 2y EFS 54% v 27% |
| Phase II (Offidani et al 2005) | ThaDD (4) | 100 | – | 41 | PR + CR 89% | 2y EFS 65% 2y OS 70% |
| Phase II (Williams et al 2004) | CTD (5) | 200 | 2–6 cycles | 15 | PR + CR = 100% | – |
| Phase III (Ludwig et al 2005) | TD v MP for induction (6) | 200–400 | Until PD | 146 | PR + CR 57% v 50% | – |
| T + IFN v IFN for maintenance | ||||||
| Phase III (Facon et al 2005) | MP v MPT v MEL100 | 50–400 | 1 year | 436 | – | Median PFS 17 v 28 v 19 |
Abbreviations: T, Thalidomide; D, Dexamethasone; P, prednisone; IFN, interferon α2b; PD, progressive disease; EBMT, European Group for Blood and Marrow Transplantation; MR, minimal response; PR, partial response; CR, complete response; EFS, event free survival; PFS, progression free survival; OS, overall survival; TD (1), D 40 mg d 1–4, 9–12 and 17–20 (odd cycles) d 1–4 (even cycles); TDM (2), D 12 mg/m2 d 1–4, 17–20, Thalidomide 300 mg d 1–4, 17–20, oral melphalan 8 mg/m2 d 1–4* Patients without evidence of PD received 9 additional cycles of MTD d 1–4; MP (3), Oral melphalan 4 mg/m2 d 1–7, Prednisone 40 mg/mq d 1–7; #Patients without evidence of PD in the MPT arm continued T until PD; ThaDD (4), Thalidomide 100 mg/day, pegylated liposomal doxorubicin (40 mg/m2 on day 1), dexamethasone (40 mg days 1–4, 9–12); 28-day cycle; CTD (5), Oral cyclophosphamide 500 mg, d 1, 8 and 15, thalidomide at a dose of 100 to 200 mg daily, and oral D 40 mg on d 1–4 and 15–18. TD v MP (6), TD: Thalidomide 200 to 400 mg/day, D 40 mg days 1–4 and 15–18 (odd cycles) and days 1–4 (even cycles); MP: M 0.25 mg/kg d 1–4, P 2 mg/kg d 1–4.