Table 2.
Summary of treatment responses in the whole study population (intention to treat, N = 80)
| Response | After induction therapy | At 3 months after ASCT | Len maintenance 1 year after ASCT | Len maintenance 2 years after ASCT | Len maintenance 3 years after ASCT | Best response at any time+ |
|---|---|---|---|---|---|---|
| sCR (N (%)) | 8 (10) | 12 (15) | 13 (16) | 16 (20) | 16 (20) | 30 (38) |
| CR (N (%)) | 4 (5) | 6 (8) | 9 (11) | 7 (9) | 5 (6) | 8 (10) |
| VGPR (N (%)) | 28 (35) | 25 (31) | 14 (18) | 10 (13) | 7 (9) | 16 (20) |
| PR (N (%)) | 28 (35) | 10 (13) | 5 (6) | 1 (1) | 1 (1) | 17 (21) |
| SD (N (%)) | 2 (3) | 1 (1) | 0 | 0 | 0 | 1 (1) |
| Cumulative PD (N (%)) | 1 (1) | 11 (14) | 20 (25) | 26 (33) | 30 (38) | - |
| Flow-MRD negative^ (N (%)) | 23 (29) | 28 (35) | 21 (26) | 18 (23) | 12 (15) | 42 (53) |
| PCR-MRD negative^ (N (%)) | 4 (5) | 8 (10) | 7 (9) | 8 (10) | 3 (4) | 22 (28) |
| Cumulative withdrawn* (N (%)) | 9 (11) | 15 (19) | 19 (24) | 20 (25) | 21 (26) | - |
ASCT, autologous stem cell transplantation; CR, complete response; Len, lenalidomide; MRD, minimal residual disease; nCR, near complete response; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response
^Regardless of serological response
*Withdrawn at induction phase: 1 with other cancer < 5 years, 1 with neutropenia; at mobilization or ASCT before lenalidomide maintenance start, 1 with simultaneous other cancer, 1 with thrombosis, 1 not eligible to ASCT, 1 death, 1 liver toxicity, 1 infection toxicity, 1 with severe sepsis syndrome, 1 with comorbidities, 3 received allogeneic SCT, 1 psychiatric illness, 1 rash +response could not be evaluated due to early withdrawal for 7 patients and one patient progressed early during induction