Table 1.

Baseline characteristics of patients

Clinical variablesbsAb (N = 36)CAR-T (N = 26)Total (N = 62)P value
Median age (range) 66.5 (63.7-73.2) 65.5 (63-70) 66 (63-72) .40 
Sex    .22 
 Female 18 (50.0%) 9 (34.6%) 27 (43.5%)  
 Male 18 (50.0%) 17 (65.4%) 35 (56.5%)  
Ethnicity    .20 
 African American 7 (19.4%) 2 (7.7%) 9 (14.5%)  
 Caucasian 29 (80.6%) 23 (88.5%) 52 (83.9%)  
 Others 0 (0.0%) 1 (3.8%) 1 (1.6%)  
Immunochemical subtype     
 IgG 24 (66.7%) 14 (53.8%) 38 (61.3%)  
 IgA 10 (27.8%) 4 (15.4%) 14 (22.6%)  
 IgD 1 (3.8%) 1 (1.6%)  
 κ light chain 2 (5.6%) 3 (11.5%) 5 (8%)  
 Λ light chain 4 (15.4%) 4 (8%)  
Median prior lines of therapy (range) 6 (5-7) 3.5 (2-6) 5 (4-6) <.001 
Triple class refractory 36 (100.0%) 14 (53.8%) 50 (80.6%) <.001 
ISS stage    .844 
 I 6 (28.6%) 4 (23.5%) 10 (26.3%)  
 II 7 (33.3%) 5 (29.4%) 12 (31.6%)  
 III 8 (38.1%) 8 (47.1%) 16 (42.1%)  
R-ISS stage    .371 
 I 3 (37.5%) 4 (26.7%) 7 (30.4%)  
 II 5 (62.5%) 7 (46.7%) 12 (52.2%)  
 III 0 (0.0%) 4 (26.7%) 4 (17.4%)  
CRS grade*    .52 
 1 12 (33.3%) 6 (23.1%) 18 (29.0%)  
 2 2 (5.6%) 3 (11.5%) 5 (8.1%)  
Median time to therapy from diagnosis, y 6.6 (0.83-15.5) 2.6 (0.35-14.4) 5.2 (0.3-15.5) .04 
Use of tocilizumab 4 (28.6%) 5 (55.6%) 9 (39.1%) .38 
Median follow in months (range), mo 8.5 (3.5-10.5) 8.9 (3.1-18.1) 9 (3.1-18) .81 
Median IgG levels (mg/L) at start of therapy (range) 889 (333-1931) 605 (259-1315) 673 (281-1826) .13 
Baseline hypogammaglobinemia (≤700 mg/dL) 20 (80.0%) 13 (72.2%) 33 (76.7%) .551 
Baseline severe hypogammaglobinemia (≤400 mg/dL) 11 (44.0%) 8 (44.4%) 19 (44.2%) .97 
Baseline lymphopenia (≤300/mL) 8 (23.5%) 8 (30.8%) 16 (26.7%) .53 
IVIG supplementation 8 (22.9%) 6 (25%) 14 (23.7%) .84 
Cumulative infections 25 30 .01 
Number of bacterial infections (n) 12 13 .11 
Number of viral infections (n) 10 .69 
Aggregated hospitalizations for infection (n) 15 18 .03 
Average length of stay per patient, mean (SD) 4.833 (3.460) 9.000 (5.196) 5.667 (4.030) .11 
Best response    .75 
 PD 7 (25.9%) 6 (30.0%) 13 (27.7%)  
 ≥PR 20 (74.1%) 14 (70.0%) 34 (72.3%)  
Clinical variablesbsAb (N = 36)CAR-T (N = 26)Total (N = 62)P value
Median age (range) 66.5 (63.7-73.2) 65.5 (63-70) 66 (63-72) .40 
Sex    .22 
 Female 18 (50.0%) 9 (34.6%) 27 (43.5%)  
 Male 18 (50.0%) 17 (65.4%) 35 (56.5%)  
Ethnicity    .20 
 African American 7 (19.4%) 2 (7.7%) 9 (14.5%)  
 Caucasian 29 (80.6%) 23 (88.5%) 52 (83.9%)  
 Others 0 (0.0%) 1 (3.8%) 1 (1.6%)  
Immunochemical subtype     
 IgG 24 (66.7%) 14 (53.8%) 38 (61.3%)  
 IgA 10 (27.8%) 4 (15.4%) 14 (22.6%)  
 IgD 1 (3.8%) 1 (1.6%)  
 κ light chain 2 (5.6%) 3 (11.5%) 5 (8%)  
 Λ light chain 4 (15.4%) 4 (8%)  
Median prior lines of therapy (range) 6 (5-7) 3.5 (2-6) 5 (4-6) <.001 
Triple class refractory 36 (100.0%) 14 (53.8%) 50 (80.6%) <.001 
ISS stage    .844 
 I 6 (28.6%) 4 (23.5%) 10 (26.3%)  
 II 7 (33.3%) 5 (29.4%) 12 (31.6%)  
 III 8 (38.1%) 8 (47.1%) 16 (42.1%)  
R-ISS stage    .371 
 I 3 (37.5%) 4 (26.7%) 7 (30.4%)  
 II 5 (62.5%) 7 (46.7%) 12 (52.2%)  
 III 0 (0.0%) 4 (26.7%) 4 (17.4%)  
CRS grade*    .52 
 1 12 (33.3%) 6 (23.1%) 18 (29.0%)  
 2 2 (5.6%) 3 (11.5%) 5 (8.1%)  
Median time to therapy from diagnosis, y 6.6 (0.83-15.5) 2.6 (0.35-14.4) 5.2 (0.3-15.5) .04 
Use of tocilizumab 4 (28.6%) 5 (55.6%) 9 (39.1%) .38 
Median follow in months (range), mo 8.5 (3.5-10.5) 8.9 (3.1-18.1) 9 (3.1-18) .81 
Median IgG levels (mg/L) at start of therapy (range) 889 (333-1931) 605 (259-1315) 673 (281-1826) .13 
Baseline hypogammaglobinemia (≤700 mg/dL) 20 (80.0%) 13 (72.2%) 33 (76.7%) .551 
Baseline severe hypogammaglobinemia (≤400 mg/dL) 11 (44.0%) 8 (44.4%) 19 (44.2%) .97 
Baseline lymphopenia (≤300/mL) 8 (23.5%) 8 (30.8%) 16 (26.7%) .53 
IVIG supplementation 8 (22.9%) 6 (25%) 14 (23.7%) .84 
Cumulative infections 25 30 .01 
Number of bacterial infections (n) 12 13 .11 
Number of viral infections (n) 10 .69 
Aggregated hospitalizations for infection (n) 15 18 .03 
Average length of stay per patient, mean (SD) 4.833 (3.460) 9.000 (5.196) 5.667 (4.030) .11 
Best response    .75 
 PD 7 (25.9%) 6 (30.0%) 13 (27.7%)  
 ≥PR 20 (74.1%) 14 (70.0%) 34 (72.3%)  

p value of less than .05 is statistically significant. PD, progressive disease; PR, partial response.

*The grading and management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) was done in accordance with specific trial protocol.

†Accounted for functional hypogammaglobinemia in IgG isotype.

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