Table 3.
Characteristics immediately prior to ASCT (“pre-ASCT”), both for the entire cohort (n=234) and split by treatment group, i.e. patients that proceeded directly to salvage ASCT (n=46) or received re-induction (n=188).
| Characteristic | Entire cohort n=234 | Direct to ASCT n=46 | Re-induction n=188 | P |
|---|---|---|---|---|
| Age at ASCT, median (range) | 64 (29-76) | 64 (29-74) | 63.5 (39-76) | .58 |
| Time period of ASCT, n (%) | ||||
| January 1, 2013 and after | 106 (45) | 17 (37) | 89 (47) | .25 |
| December 31, 2012 and before | 128 (55) | 29 (63) | 99 (53) | |
| Time from T0 to ASCT in months, median (range)* | 5.3 (0.2-37.0) | 2.3 (0.2-37.0) | 5.9 (1.2-18.0) | <.0001 |
| Serum creatinine (mg/dL), median (range)† | 1.0 (0.5-6.8) | 1.0 (0.5-5.1) | 0.9 (0.5-6.8) | .15 |
| Serum M-protein present, n (%)† | 179 (76) | 38 (83) | 141 (75) | .33 |
| Serum M-protein (g/dL), median (range)†§ | 0.8 (0.01-6.1) | 1.3 (0.01-6.1) | 0.8 (0.01-5.9) | .07 |
| Urine M-protein present, n (%)† | 148 (67) | 35 (78) | 113 (64) | .11 |
| Abnormal serum free light chain ratio, n (%)† | 187 (82) | 42 (91) | 145 (79) | .09 |
| Serum albumin (g/dL), median (range)† | 3.4 (2.4-4.1) | 3.4 (2.8-4.1) | 3.4 (2.4-4.1) | .80 |
| Serum B-2-microglobulin (µg/mL), median (range)† | 2.9 (1.2-32.1) | 3.2 (1.6-19.2) | 2.8 (1.2-32.1) | .17 |
| Abnormal B2M (≥3.5 µg/mL), n (%) | 70 (31) | 18 (39) | 52 (28) | .21 |
| Serum LDH (IU/L), median (range)† | 185 (100-819) | 174 (100-380) | 189 (105-819) | .13 |
| Abnormal LDH (≥222 IU/L), n (%) | 52 (23) | 8 (17) | 44 (24) | .43 |
| Bone marrow plasma cell %, median (range)† | 5 (0-95) | 15 (0-80) | 5 (0-95) | .0018 |
| Disease status relative to T0, n (%)*† | ||||
| ≥VGPR (after 1-2 lines‡) | 46 (20) | 0 | 46 (24) | <.0001 |
| PR or Stable Disease (after 1-2 lines‡) | 78 (33) | 0 | 78 (41) | |
| Relapsed/Refractory (and/or ≥3 lines‡) | 110 (47) | 46 (100) | 64 (34) | |
| Melphalan dose, n (%) | ||||
| 200 mg/m2 | 190 (81) | 38 (83) | 152 (81) | .35 |
| Reduced-dose (e.g. 140 mg/m2) | 39 (17) | 6 (13) | 33 (18) | |
| Other (e.g. +proteasome inhibitor) | 5 (2) | 2 (4) | 3 (2) | |
| CD34+ cell dose (×106 cells/kg), median (range) | 4.19 (2.06-12.69) | 4.19 (2.48-10.96) | 4.19 (2.06-12.69) | .70 |
| Maintenance post-ASCT, n (%) | 82 (35) | 15 (33) | 67 (36) | .58 |
| Consolidation post-ASCT, n (%) | 6 (3) | 0 | 6 (3) | .60 |
Bold denotes p<.05
*
T0 is the date of progression, after which salvage ASCT was deemed necessary.
†
Pre-ASCT, i.e. laboratory findings immediately prior to the date of stem cell infusion (Day 0).
‡
Lines of re-induction therapy after T0, prior to salvage ASCT.
§
Among patients with measurable serum M-protein. Unmeasurable fragments counted as 0.01 g/dL.