Table 3.
Recent Randomized Trials in Non-Transplant Candidates with Newly Diagnosed Myeloma
| GIMEMA | IFM 99-06 | IFM 01-01 | NMSG | HOVON | VISTA | |
|---|---|---|---|---|---|---|
| Number of patients | 331 | 447 | 232 | 363 | 344 | 682 |
| Median age (range) | 72 (60-85) | 69 (65-75) | 78.5 (75-89) | 75 (49-92) | 72 | 71 (48-91) |
| MP regimen | 6 4-week cycles |
12 6-week cycles |
12 6-week cycles |
6-week cycles until plataeu |
8 4-week cycles |
9 6-week cycles |
| Melphalan dose | 4 mg/m2 days 1-7 |
0.25 mg/kg days 1-4 |
0.2 mg/kg days 1-4 |
0.25 mg/kg days 1-4 |
0.25 mg/kg days 1-5 |
9 mg/m2 days 1-4 |
| Prednisone dose | 40 mg/m2 days 1-7 |
2 mg/kg days 1-4 |
2 mg/kg days 1-4 |
100 mg days 1-4 |
1 mg/kg days 1-5 |
60 mg/m2 days 1-4 |
| Thalidomide dose | 100 mg | Up to 400 mg |
100 mg | Up to 400 mg |
200 | Bortezomib* |
| Maintenance | Yes | No | No | Yes | Yes | No |
| PR | 60.4 vs. 45.2 | 76 vs. 35 | 62 vs. 31 | 27 vs. 22 | 36 vs. 37 | 33 vs. 31 |
| CR | 15.5 vs. 2.4 | 13 vs. 2 | 21 vs. 7 | 15 vs. 6 | 2 vs. 2 | 30 vs 4 |
| PFS (months, median) | 21.8 vs. 15.5 | 27.5 vs. 17.8 | 24.1 vs. 18.5 |
16 vs. 14 | 13 vs. 10 | 24 vs 16** |
| OS (months, median) | 45.0 vs. 47.6 | 51.6 vs. 33.2 | 44.0 vs. 29.1 |
29 vs. 33 | 37 vs. 30 | No reached*** |
*
Bortezomib 1.3 mg/m2 days 1, 4, 8, 11, 22, 25, 29, 32 in cycles 1-4 and on days 1, 8, 22, and 29 during cycles 5-9
**
Time to progression
***
Hazard ratio 0.61 (P=0.008) in favour of MPV