Table 1 Baseline characteristics in patients by toxicity group.
Whole Cohort (n = 174) | Control (n = 146) | IEC-Nerve Palsy (n = 14) | IEC-Parkinsonism (n = 9) | |||
|---|---|---|---|---|---|---|
p value | p value | |||||
At time of Evaluation | ||||||
Age, years, median (range) | 65 (31-86) | 64 (31-82) | 66.5 (45-86) | 0.214 | 76 (67-80) | 0.0004 |
Age, >75 years, n (%) | 15 (9%) | 8 (5%) | 2 (14%) | 0.62 | 5 (56%) | 0.0011 |
Sex, male, n (%) | 93 (53%) | 78 (53%) | 7 (50%) | 1.00 | 5 (56%) | 1.00 |
ECOG 0-1a, n (%) | 128 (91%) | 116 (91%) | 12 (100%) | 0.35 | 9 (100%) | 0.13 |
Myeloma type, IgG, n (%) | 101 (58%) | 83 (57%) | 8 (57%) | 1.00 | 7 (78%) | 0.31 |
Del(17p)b, n (%) | 46 (28%) | 36 (26%) | 3 (23%) | 1.00 | 3 (33%) | 0.70 |
1q gain/amplificationc, n (%) | 85 (52%) | 70 (51%) | 5 (38%) | 0.56 | 7 (78%) | 0.17 |
R-ISS Stage IIId, n (%) | 16 (14%) | 14 (15%) | 0 (0%) | 0.35 | 1 (17%) | 1.00 |
Extramedullary Disease, n (%) | 33 (19%) | 30 (21%) | 3 (21%) | 1.00 | 0 (0%) | 0.21 |
1-3 prior lines of therapy, n (%) | 50 (29%) | 39 (27%) | 6 (43%) | 0.22 | 5 (56%) | 0.12 |
Prior ASCT, n (%) | 151 (87%) | 129 (88%) | 9 (64%) | 0.027 | 8 (89%) | 1.00 |
Lenalidomide Refractory, n (%) | 135 (78%) | 117 (80%) | 8 (62%) | 0.18 | 8 (89%) | 1.00 |
Triple-Class Refractory, n (%) | 122 (70%) | 105 (72%) | 7 (50%) | 0.12 | 7 (78%) | 1.00 |
Penta-Drug Refractory, n (%) | 48 (28%) | 43 (29%) | 2 (14%) | 0.35 | 1 (11%) | 0.45 |
BCMA exposed/refractory, n (%) | 10 (6%) | 9 (6%) | 0 (0%) | 1.00 | 0 (0%) | 1.00 |
Treatment Characteristics at time of Lymphodepletion | ||||||
Out of Specification, n (%) | 31 (18%) | 27 (18%) | 2 (14%) | 1.00 | 0 (0%) | 0.36 |
Bridging therapy, n (%) | 139 (80%) | 114 (78%) | 13 (93%) | 0.30 | 8 (89%) | 0.69 |
Type of Bridginge, n (%) | 0.19 | 0.81 | ||||
Alkylator-based | 42 (30%) | 33 (29%) | 4 (31%) | 2 (25%) | ||
Novel agent combinations | 85 (62%) | 69 (60%) | 9 (69%) | 6 (75%) | ||
Bispecific antibody | 9 (6%) | 9 (8%) | 0 (0%) | 0 (0%) | ||
Radiation therapy | 3 (2%) | 3 (3%) | 0 (0%) | 0 (0%) | ||
Tumor Burden at time of Lymphodepletion | ||||||
Bone Marrow Plasma Cellf, %, median (range) | 5 (0–95) | 4 (0-95) | 2.5 (0–35) | 0.58 | 25 (1–60) | 0.03 |
Bone Marrow Plasma Cell ≥20%f, n (%) | 45 (28%) | 37 (28%) | 2 (15%) | 0.51 | 5 (63%) | 0.05 |
Involved FLC, mg/dL, median (range) | 6.4 (0.06–343) | 6.9 (0.11–343) | 0.94 (0.06–34.5) | 0.0073 | 21.1 (1.0–107) | 0.26 |
Involved FLC ≥ 20 mg/dLg, n (%) | 52 (34%) | 43 (33%) | 1 (8%) | 0.06 | 5 (63%) | 0.05 |
M-protein levelh, g/dL, median (range) | 0.6 (0–25.1) | 0.6 (0–25.1) | 0.6 (0–2.4) | 0.76 | 0.8 (0.2–3.0) | 0.54 |
Elevated LDH, n (%) | 48 (28%) | 41 (28%) | 3 (21%) | 0.76 | 3 (33%) | 0.72 |