Comparison of 200 mg/m2 melphalan and 8 Gy total body irradiation (TBI) plus 140 mg/m2 melphalan as conditioning regimen for ASCT in multiple myeloma (IFM 9502 Trial).
| . | HDM 140 + TBI (N = 140) . | HDM 200 (N = 142) . | P . |
|---|---|---|---|
| Abbreviations: ASCT, autologous stem cell transplantation; CR, complete remission; EFS, event-free survival; HDM, high dose melphalan; IFM, Intergroupe Français du Myélome; NR, not reached; TBI, total body irradiation; VGPR, very good partial remission. | |||
| Toxicity | |||
| Median duration of neutropenia (days) | 10 | 8 | < 0.001 |
| Median no. of platelet transfusions | 2 | 1 | < 0.001 |
| Median duration of hospitalization (days) | 23 | 19 | < 0.001 |
| Mucositis (grade 3-4), % | 51 | 30 | < 0.001 |
| Pulmonary toxicity (grade 3-4), % | 6.4 | 1.4 | 0.06 |
| Toxic death | 5 | 0 | 0.07 |
| Efficacy | |||
| CR + VGPR, % | 43 | 55 | 0.06 |
| Median EFS, mos. | 21 | 20.5 | 0.6 |
| Median survival, mos. | 43 | NR | 0.05 |
| . | HDM 140 + TBI (N = 140) . | HDM 200 (N = 142) . | P . |
|---|---|---|---|
| Abbreviations: ASCT, autologous stem cell transplantation; CR, complete remission; EFS, event-free survival; HDM, high dose melphalan; IFM, Intergroupe Français du Myélome; NR, not reached; TBI, total body irradiation; VGPR, very good partial remission. | |||
| Toxicity | |||
| Median duration of neutropenia (days) | 10 | 8 | < 0.001 |
| Median no. of platelet transfusions | 2 | 1 | < 0.001 |
| Median duration of hospitalization (days) | 23 | 19 | < 0.001 |
| Mucositis (grade 3-4), % | 51 | 30 | < 0.001 |
| Pulmonary toxicity (grade 3-4), % | 6.4 | 1.4 | 0.06 |
| Toxic death | 5 | 0 | 0.07 |
| Efficacy | |||
| CR + VGPR, % | 43 | 55 | 0.06 |
| Median EFS, mos. | 21 | 20.5 | 0.6 |
| Median survival, mos. | 43 | NR | 0.05 |