Table 1 Baseline characteristics in patients by toxicity group.

From: Clinical course, risk factors and mitigating strategies for Immune effector cell-associated late onset neurotoxicities after ciltacabtagene autoleucel CAR-T in multiple myeloma

 

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

  1. ASCT Autologous Stem Cell Transplantation, BCMA B-cell maturation antigen, ECOG Eastern Cooperative Oncology Group, FLC Free Light Chain, LDH Lactate Dehydrogenase, R-ISS Revised International Scoring System.
  2. a34 missing.
  3. b10 missing.
  4. c10 missing.
  5. d62 missing.
  6. e34 missing.
  7. f15 missing.
  8. g18 missing.
  9. h42 missing.