Table 4. Comparison of ASCT Outcomes in Patients Who Received Generic and Innovator MEL.
| ASCT Outcomes Days (Range) | Generic MEL (n = 33) | Innovator MEL (n = 30) | P |
|---|---|---|---|
| Day of Onset of Mucositis (Range) | 3(1-7) | 3(1-7) | NS |
| Mucositis Grade | NS | ||
| 3 | 1 | – | |
| 2 | 18 | 16 | |
| 1 | 14 | 14 | |
| Duration to Neutrophil Engraftment | 12 (10-16) | 12 (10-21) | NS |
| Duration to Platelet Engraftment | 16 (13-33) | 17 (14-33) | NS |
| Duration of Hospitalization | 22 (17-55) | 21 (15-42) | NS |
| Day 100 Post ASCT Response | NS | ||
| CR | 20 | 16 | |
| VGPR | 9 | 4 | |
| PR | 1 | 4 | |
| Others a | 3 | 6 |
Abbreviations: ASCT = autologous stem cell transplantation; CR = complete response; MEL = melphalan; NS = not significant; PR = partial response; VGPR = very good partial response.
a
Others includes in generic MEL (1 expired, 1 progression, and 1 response not reached) and in innovator MEL (4, response not reached and 2, lost to follow-up).