Table 1 Baseline patient characteristics
Patient characteristics | All patients (n = 113) | HT low (n = 63) | HT high (n = 50) | P |
|---|---|---|---|---|
Demographic features | ||||
Median age, years (range) | 65 (39–81) | 65 (46–81) | 66 (39–77) | 0.36 |
Sex, female, n (%) | 48 (42%) | 27 (43%) | 21 (42%) |  > 0.9 |
Race, Black vs. not#, n (%) | 23/102 (23.2%) | 10/55 (19.2%) | 13/47 (27.7%) | 0.34 |
ECOG PS at lymphodepletion | ||||
 Median (95% CI) | 1 (0–1) | 0 (0–1) | 1 (1–1) |  < 0.001 |
 PS ≥ 2, n (%) | 12 (9%) | 0 (0%) | 12 (24%) |  < 0.001 |
Country, USA, n (%) | 89 (79%) | 47 (75%) | 42 (84%) | 0.25 |
Disease features | ||||
Extramedullary disease, n (%) | 51 (45.1%) | 27 (42.9%) | 24 (48%) | 0.70 |
Revised ISS stage 3, n (%) | 12/79 (15.2%) | 3/40 (7.5%) | 9/39 (23.1%) | 0.066 |
Triple refractory disease, n (%) | 92 (81.4%) | 53 (84.1%) | 39 (78%) | 0.47 |
Penta refractory disease, n (%) | 48 (42.5%) | 28 (44.4%) | 20 (40%) | 0.70 |
Any high-risk cytogenetic abnormality (del(17p), t(4;14), (14;16)), n (%) | 31/105 (29.5%) | 14/56 (25.0%) | 17/49 (34.7%) | 0.29 |
Gain1q, n (%) | 28/99 (28.3%) | 11/52 (21.2%) | 17/47 (36.2%) | 0.12 |
Serum LDH | ||||
 Median (U/l), 95% CI | 208 (194–218) | 197 (188–213) | 221 (201–278) | 0.049 |
 > ULN, n (%) | 36 (31.9%) | 13 (20.6%) | 23 (46%) | 0.005 |
Median serum albumin (g/dL), 95% CI | 3.8 (3.6–3.9) | 3.9 (3.8–4.1) | 3.4 (3.2–3.6) |  < 0.001 |
Median serum beta-2-microglobulin (mg/L), 95% CI | 3.1 (2.6–3.4) n = 83 | 2.6 (2.3–3.1) n = 45 | 4.0 (3.1–4.4) n = 38 | 0.001 |
CAR product | ||||
Ide-cel, n (%) | 106 (94%) | 61 (97%) | 45 (90%) | 0.24 |
Cilta-cel, n (%) | 7 (6%) | 2 (3%) | 5 (10%) | Â |
Prior therapy | ||||
Median lines of prior therapy, 95% CI | 6 (5–6) | 6 (5–7) | 6 (5–6) | 0.19 |
Prior BCMA-directed therapy, n (%) | ||||
 Bispecific or ADC | 12/96 (13%) | 2/51 (4%) | 10/45 (22%) | 0.01 |
Exposure to alkylating Chemotherapy in the 3Â months before CAR-T, n (%) | 42 (37%) | 20 (32%) | 22 (44%) | 0.24 |
Bridging therapy, n (%) | 76 (67%) | 40 (64%) | 36 (72%) | 0.42 |
Response to bridging therapy, n (%)* | Â | Â | Â | 0.66 |
 PR or better | 7/67 (10%) | 4/33 (12%) | 3/34 (9%) |  |
 SD/PD | 60/67 (90%) | 29/33 (88%) | 31/34 (91%) |  |
Alkylating-based bridging therapy, n (%) | 23 (20%) | 10 (16%) | 13 (26%) | 0.24 |
Prior autologous SCT, n (%) | 99 (88%) | 52 (83%) | 47 (94%) | 0.087 |
Prior allogeneic SCT, n (%) | 4 (3.5%) | 2 (3.2%) | 2 (4.0%) |  > 0.9 |
Kidney function | ||||
Creatinine clearance—at LD (eGFR) |  |  |  | 0.009 |
 > 60 ml/min—n (%) | 84 (74%) | 53 (84%) | 31 (62%) |  |
 30–60 ml/min—n (%) | 25 (22%) | 10 (16%) | 15 (30%) |  |
 < 30 ml/min—n (%) | 4 (4%) | 0 (0%) | 4 (8%) |  |
BM studies | ||||
Median plasma cells in BM (%), 95% CI | 3 (1.5–11) | 2.5 (0.5–5) | 15 (1.5–65) | 0.013 |
BM plasma Cells > 5%—n (%) | 52 (46.0%) | 23 (36.5%) | 29 (58%) | 0.036 |
BM plasma Cells > 50%—n (%) | 28 (24.8%) | 7 (11.1%) | 21 (42%) |  < 0.001 |
CAR-HEMATOTOX Components [8] | ||||
Median C-reactive protein (mg/dl), 95% CI | 0.58 (0.40–0.92) | 0.45 (0.37–0.65 | 1.02 (0.42–2.50) | 0.03 |
Median ferritin (ng/ml), 95% CI | 211 (120–354) | 86 (64–141) | 811 (625–1158) |  < 0.001 |
Median ANC (G/l), 95% CI | 2.47 (1.98–2.84) | 2.95 (2.30–3.30) | 1.77 (1.31–2.49) |  < 0.001 |
Median platelet count (G/l), 95% CI | 144 (125–158) | 181 (163–209) | 63 (49–93) |  < 0.001 |
Median hemoglobin (g/dl), 95% CI | 10.5 (9.7–11.1) | 11.6 (11.1–1.9) | 8.5 (8.2–9.2) |  < 0.001 |
Median CAR-HEMATOTOX score, 95% CI | 1 (1–2) | 1 (0–1) | 3.5 (3–4) |  < 0.001 |