Table 1 Clinical relevance of baseline demographics
Parameters | Total | Non-PD | PD/Death | p value |
|---|---|---|---|---|
Number of patients | 74 | 12 | 62 | |
Host Characteristics | ||||
Age (years) | ||||
Median (range) | 54.5 (27 ∼ 74) | 52.5 (35 ∼ 68) | 55.0 (27 ∼ 74) | 0.5654 |
ECOG performance status (n) | ||||
0 | 30 (40.5%) | 8 (66.7%) | 22 (35.5%) | 0.0144 |
1 | 32 (43.2%) | 1 (8.3%) | 31 (50.0%) | |
2 | 12 (16.2%) | 3 (25.0%) | 9 (14.5%) | |
Myeloma subtype (n) | ||||
IgG | 33 (44.6%) | 9 (75.0%) | 24 (38.7%) | 0.0206 |
IgA | 21 (28.4%) | 3 (25.0%) | 18 (29.0%) | 1.0000 |
IgD | 1 (1.4%) | 0 | 1 (1.6%) | 1.0000 |
Kappa | 7 (9.5%) | 0 | 7 (11.3%) | 0.5901 |
Lambda | 12 (16.2%) | 0 | 12 (19.4%) | 0.1953 |
Tumor Burden | ||||
ISS staging (n) | ||||
I | 33 (44.6%) | 8 (66.7%) | 25 (40.3%) | 0.3824 |
II | 14 (18.9%) | 1 (8.3%) | 13 (21.0%) | |
III | 21 (28.4%) | 3 (25.0%) | 18 (29.0%) | |
Unknown | 6 (8.1%) | 0 | 6 (9.7%) | |
Durie-Salmon system (n) | ||||
IIA | 8 (10.8%) | 2 (16.7%) | 6 (9.7%) | 0.5751 |
IIB | 1 (1.4%) | 0 | 1 (1.6%) | |
III§ | 3 (4.1%) | 0 | 3 (4.8%) | |
IIIA | 44 (59.5%) | 7 (58.3%) | 37 (59.7%) | |
IIIB | 9 (12.2%) | 0 | 9 (14.5%) | |
Unknown | 9 (12.2%) | 3 (25.0%) | 6 (9.7%) | |
Extramedullary plasmacytoma (n) | ||||
Yes | 22 (29.7%) | 0 | 22 (35.5%) | 0.0139 |
No | 52 (70.3%) | 12 (100.0%) | 40 (64.5%) | |
Tumor biology | ||||
Cytogenetic abnormalities (n) | 42 | 8 | 34 | |
Standard risk | 9 (21.4%) | 1 (12.5%) | 8 (23.5%) | 0.6622 |
High risk | 33 (78.6%) | 7 (87.5%) | 26 (76.5%) | |
t(4;14) | 5 (11.9%) | 1 (12.5%) | 4 (11.8%) | |
t(14;16) | 0 | 0 | 0 | |
t(14;20) | 0 | 0 | 0 | |
del(17p) | 11 (26.2%) | 2 (25.0%) | 9 (26.5%) | |
gain(1q) | 29 (69.0%) | 7 (87.5%) | 22 (64.7%) | |
Double-hit†| 10 (23.8%) | 3 (37.5%) | 7 (20.6%) | |
Triple-hit‡ | 1 (2.4%) | 0 | 1 (2.9%) | |
Serum β2-microglobuline (mg/L) | ||||
Mean (SD) | 5.8 (4.7) | 4.1 (2.4) | 6.1 (4.9) | 0.1039 |
Median (range) | 3.9 (1.7 ∼ 31.7) | 3.7 (1.9 ∼ 9.0) | 4.3 (1.7 ∼ 31.7) | |
Previous medical history | ||||
Time from initial MM diagnosis (years) | ||||
Mean (SD) | 3.9 (2.1) | 3.5 (2.2) | 4.0 (2.0) | 0.3445 |
Median (range) | 4.0 (1 ∼ 9) | 3.0 (1 ∼ 9) | 4.0 (1 ∼ 9) | |
Number of prior lines of therapy (n) | ||||
Mean (SD) | 3.2 (1.8) | 2.8 (1.5) | 3.3 (1.8) | 0.2797 |
Median (range) | 3.0 (1 ∼ 9) | 2.0 (1 ∼ 6) | 3.0 (1 ∼ 9) | |
CAR T treatment scheme | ||||
Total CAR T cells (×106/kg) | ||||
Median (range) | 0.5 (0.1–2.1) | 0.4 (0.2–1.6) | 0.5 (0.1–2.1) | 0.7204 |
Infusion mode (n) | ||||
Unfractionated infusion | 9 (12.2%) | 0 | 9 (14.5%) | 0.3392 |
fractionated infusion | 65 (87.8%) | 12 (100.0%) | 53 (85.5%) | |
Preconditioning therapy (n) | ||||
Cyclophosphamide | 66 (89.2%) | 8 (66.7%) | 58 (93.5%) | 0.0204 |
Fludarabine + Cyclophosphamide | 8 (10.8%) | 4 (33.3%) | 4 (6.5%) | |