Summary of results from 7 randomized trials
| . | Trial design . | Time of thal . | Thal dose, mg . | Intended thal, mo . | Actual thal, mo . | Median follow-up, mo . | Outcomes . | P . |
|---|---|---|---|---|---|---|---|---|
| TT2* | TT2 ± thal | I, T, C, M | 400 | Continuous | > 30 | 72 | 8-y OS: 57% vs 44% | .09 |
| Abnormal cytogenetics subgroup | I, T, C, M | 400 | Continuous | > 30 | 72 | 5-y OS: 56% vs 43% | .02 | |
| IFM 99-02†2 | ASCT × 2 ± thal | M | 400 | Continuous | 15 | 39 | 4-y OS: 87% vs 76% | .04 |
| Tunisian3 | ASCT × 2 vs ASCT × 1 + 6 mo thal | C | 100 | 6 | NA | 33 | 3-y OS: 85% vs 65% | .04 |
| ALLG MM64 | ASCT × 1→prednisolone maintenance ± thal × 1 y | C | 200 | 12 | NA | NA | 2-y OS: 91% vs 80% | .02 |
| IFM 99-066 | MP vs MPT vs Mel 100 × 2 (age 65-75) | I | 400 | 18 | 11 | 51 | MS: 52 vs 33 mo | < .001 |
| IFM 01-018 | MP vs MPT (age > 75) | I | 200 | 18 | 13 | NA | MS: 45 vs 28 mo | .03 |
| GIMEMA5 | MP vs MPT | I, M | 100 | Continuous | 9.6 | 31 | MS: 45 vs 48 mo | NS |
| Nordic7 | MP vs MPT | I, M | 400 | Continuous | NA | NA | MS: 28 vs 33 mo | NS |
| . | Trial design . | Time of thal . | Thal dose, mg . | Intended thal, mo . | Actual thal, mo . | Median follow-up, mo . | Outcomes . | P . |
|---|---|---|---|---|---|---|---|---|
| TT2* | TT2 ± thal | I, T, C, M | 400 | Continuous | > 30 | 72 | 8-y OS: 57% vs 44% | .09 |
| Abnormal cytogenetics subgroup | I, T, C, M | 400 | Continuous | > 30 | 72 | 5-y OS: 56% vs 43% | .02 | |
| IFM 99-02†2 | ASCT × 2 ± thal | M | 400 | Continuous | 15 | 39 | 4-y OS: 87% vs 76% | .04 |
| Tunisian3 | ASCT × 2 vs ASCT × 1 + 6 mo thal | C | 100 | 6 | NA | 33 | 3-y OS: 85% vs 65% | .04 |
| ALLG MM64 | ASCT × 1→prednisolone maintenance ± thal × 1 y | C | 200 | 12 | NA | NA | 2-y OS: 91% vs 80% | .02 |
| IFM 99-066 | MP vs MPT vs Mel 100 × 2 (age 65-75) | I | 400 | 18 | 11 | 51 | MS: 52 vs 33 mo | < .001 |
| IFM 01-018 | MP vs MPT (age > 75) | I | 200 | 18 | 13 | NA | MS: 45 vs 28 mo | .03 |
| GIMEMA5 | MP vs MPT | I, M | 100 | Continuous | 9.6 | 31 | MS: 45 vs 48 mo | NS |
| Nordic7 | MP vs MPT | I, M | 400 | Continuous | NA | NA | MS: 28 vs 33 mo | NS |
I indicates induction; T, transplantation; C, consolidation; M, maintenance; MS, median survival; OS, overall survival; thal, thalidomide; ASCT, autologous stem cell transplantation; Mel, melphalan; MP, melphalan and prednisone; MPT, MP and thalidomide; NA, not available; and NS, not significant.
Barlogie et al study.
Included patients with 1 or fewer risk factors (beta-2 microglobulin < 3.0 mg/L or deletion 13 by FISH).