Table 1.
Thalidomide trials in the post-ASCT setting.
| Study (authors) | N | Maintenance phase study arms | EFS | PFS | OS |
|---|---|---|---|---|---|
| IFM 99-02 (Attal et al.) AM [33] |
597 | A: no maintenance B: pamidronate C: pamidronate/thalidomide (400 mg/d) |
A: 36% B: 37% C: 52% (P < 0.009) |
A: 77% B: 74% C: 87% (P < 0.04) |
|
|
| |||||
|
TT-2*
(Barlogie et al.) AM [34] |
668 | A: thalidomide 100 mg/d × 1 year → 50 mg/d until PD B: no maintenance |
A: 6 years B: 4.1 years (P = 0.001) |
A: 57% B: 44% (P = 0.09) |
|
|
| |||||
| HOVON-50 (Lokhorst et al.) AM [35] |
556 | A: VAD induction → IFN-α maintenance B: TAD induction → thalidomide maintenance |
A: 22 months B: 34 months (P < 0.001) |
A: 25 months B: 35 months (P < 0.001) |
A: 60 months B: 73 months (P = 0.77) |
|
| |||||
| MRC myeloma IX intensive group (Morgan et al.) AM [15] |
493 | A: thalidomide (50–100 mg/d) B: no maintenance |
A: 30 months B: 27 months (P = 0.003) |
A: 75 months B: 80 months (P = 0.26) |
|
|
| |||||
| BMT CTN-0102 (Krishnan et al.) AM [16] |
436 | A: dexamethasone/thalidomide (200 mg/d) B: no maintenance |
A: 49% B: 43% (P = 0.08) |
A: 80% B: 81% (P = 0.82) |
|
|
| |||||
| (Maiolino et al.) AM [36] | 108 | A: dexamethasone/thalidomide (200 mg/d) B: dexamethasone |
A: 64% B: 30% (P = 0.002) |
A: 85% B: 70% (P = 0.27) |
|
|
| |||||
| ALLG MM-6 (Spencer et al.) AM [37] |
269 | A: prednisolone/thalidomide 100–200 mg/d × 12 months B: prednisolone |
A: 42% B: 23% (P < 0.001) |
A: 86% B: 75% (P = 0.004) |
|
|
| |||||
| NCIC CTG MY10 (Stewart et al.) AM [38] |
332 | A: prednisone/thalidomide (200 mg/d) B: no maintenance |
A: 28 months B: 17 months (P < 0.0001) |
A: 68% B: 60% (P = 0.21) |
|
*Both arms in TT-2 received the same 4 induction cycles followed by double ASCT and 4 cycles of consolidation (Figure 6). Thalidomide was given in arm A at a dose of 400 mg/d during induction, 100 mg/d during ASCT, and 200 mg/d during consolidation.