Baseline characteristics of patients infused with ide-cel
| . | Total . | Age of <65 y . | Age of ≥65 y . | P value . |
|---|---|---|---|---|
| Number of patients, n (%) | 156 | 81 (51.9) | 75 (48.1) | |
| Age at time of CART infusion, y (median) | 63.5 | 58 | 69 | <.001 |
| Range | 42-83 | 42-64 | 65-83 | |
| Sex | .71 | |||
| Male, n (%) | 98 (62.8) | 52 (64.2) | 46 (61.3) | |
| Female, n (%) | 58 (37.2) | 29 (35.8) | 29 (38.7) | |
| ECOG PS at time of lymphodepletion | .92 | |||
| 0-1, n (%) | 131 (86.8) | 67 (87.0) | 64 (86.5) | |
| ≥2, n (%) | 20 (13.3) | 10 (13.0) | 10 (13.5) | |
| Unknown | 5 | 4 | 1 | |
| Race/ethnicity | .78 | |||
| White, n (%) | 109 (69.9) | 55 (67.9) | 54 (72.0) | |
| Black, n (%) | 26 (16.7) | 13 (15.1) | 13 (17.3) | |
| Hispanic, n (%) | 9 (5.8) | 5 (6.2) | 4 (5.3) | |
| Other, n (%) | 12 (7.6) | 8 (9.9) | 4 (5.3) | |
| Myeloma subtype | .31 | |||
| IgG, n (%) | 88 (57.1) | 44 (54.3) | 44 (60.3) | |
| IgA, n (%) | 34 (22.1) | 22 (27.2) | 12 (16.4) | |
| IgM, n (%) | 1 (0.65) | 0 (0.0) | 1. (1.4) | |
| FLC, n (%) | 31 (20.1) | 15 (18.5) | 16 (21.9) | |
| Extramedullary disease, n (%) | 73 (46.8) | 42 (51.9) | 31 (41.3) | .19 |
| High marrow burden∗ (≥50%), n (%) | 42 (28.2) | 25 (33.3) | 17 (23.0) | .16 |
| R-ISS disease stage | .99 | |||
| I, n (%) | 28 (21.1) | 15 (21.4) | 13 (20.6) | |
| II, n (%) | 72 (54.1) | 38 (54.3) | 34 (54.0) | |
| III, n (%) | 33 (24.8) | 17 (24.3) | 16 (25.4) | |
| Unknown, n (%) | 23 | 11 | 12 | |
| Cytogenetic abnormality | ||||
| Any high-risk cytogenetics†, n (%) | 50 (36.5) | 24 (33.8) | 26 (39.4) | .50 |
| Unknown | 19 | 10 | 9 | |
| del(17p), n (%) | 34 (24.8) | 16 (22.5) | 18 (27.3) | .52 |
| Unknown | 18 | 10 | 9 | |
| t(4;14), n (%) | 18 (13.7) | 9 (13.2) | 9 (14.3) | .86 |
| Unknown | 25 | 13 | 12 | |
| t(14;16), n (%) | 6 (4.6) | 3 (4.5) | 3 (4.8) | .94 |
| Unknown | 26 | 14 | 12 | |
| Bridging therapy, n (%) | 116 (74.4) | 63 (77.8) | 53 (70.7) | .31 |
| Refractory status | ||||
| Immunomodulatory agent, n (%) | 144 (92.3) | 75 (92.6) | 69 (92.0) | .89 |
| Proteasome inhibitor, n (%) | 140 (89.7) | 76 (93.8) | 64 (85.3) | .081‡ |
| Anti-CD38 antibody, n (%) | 146 (93.6) | 78 (96.3) | 68 (90.7) | .15 |
| Triple-refractory§, n (%) | 140 (89.7) | 77 (95.1) | 63 (84.0) | .023 |
| Penta-refractory||, n (%) | 62 (39.7) | 38 (46.9) | 24 (32.0) | .057‡ |
| Number of prior therapies | ||||
| Median (range) | 6 (4-18) | 6 (4-16) | 6 (4-18) | .85 |
| Average | 7.1 | 6.9 | 7.2 | |
| Time between diagnosis to CART infusion, y (average, n = 131) | 7.2 | 7 | 7.4 | .49 |
| . | Total . | Age of <65 y . | Age of ≥65 y . | P value . |
|---|---|---|---|---|
| Number of patients, n (%) | 156 | 81 (51.9) | 75 (48.1) | |
| Age at time of CART infusion, y (median) | 63.5 | 58 | 69 | <.001 |
| Range | 42-83 | 42-64 | 65-83 | |
| Sex | .71 | |||
| Male, n (%) | 98 (62.8) | 52 (64.2) | 46 (61.3) | |
| Female, n (%) | 58 (37.2) | 29 (35.8) | 29 (38.7) | |
| ECOG PS at time of lymphodepletion | .92 | |||
| 0-1, n (%) | 131 (86.8) | 67 (87.0) | 64 (86.5) | |
| ≥2, n (%) | 20 (13.3) | 10 (13.0) | 10 (13.5) | |
| Unknown | 5 | 4 | 1 | |
| Race/ethnicity | .78 | |||
| White, n (%) | 109 (69.9) | 55 (67.9) | 54 (72.0) | |
| Black, n (%) | 26 (16.7) | 13 (15.1) | 13 (17.3) | |
| Hispanic, n (%) | 9 (5.8) | 5 (6.2) | 4 (5.3) | |
| Other, n (%) | 12 (7.6) | 8 (9.9) | 4 (5.3) | |
| Myeloma subtype | .31 | |||
| IgG, n (%) | 88 (57.1) | 44 (54.3) | 44 (60.3) | |
| IgA, n (%) | 34 (22.1) | 22 (27.2) | 12 (16.4) | |
| IgM, n (%) | 1 (0.65) | 0 (0.0) | 1. (1.4) | |
| FLC, n (%) | 31 (20.1) | 15 (18.5) | 16 (21.9) | |
| Extramedullary disease, n (%) | 73 (46.8) | 42 (51.9) | 31 (41.3) | .19 |
| High marrow burden∗ (≥50%), n (%) | 42 (28.2) | 25 (33.3) | 17 (23.0) | .16 |
| R-ISS disease stage | .99 | |||
| I, n (%) | 28 (21.1) | 15 (21.4) | 13 (20.6) | |
| II, n (%) | 72 (54.1) | 38 (54.3) | 34 (54.0) | |
| III, n (%) | 33 (24.8) | 17 (24.3) | 16 (25.4) | |
| Unknown, n (%) | 23 | 11 | 12 | |
| Cytogenetic abnormality | ||||
| Any high-risk cytogenetics†, n (%) | 50 (36.5) | 24 (33.8) | 26 (39.4) | .50 |
| Unknown | 19 | 10 | 9 | |
| del(17p), n (%) | 34 (24.8) | 16 (22.5) | 18 (27.3) | .52 |
| Unknown | 18 | 10 | 9 | |
| t(4;14), n (%) | 18 (13.7) | 9 (13.2) | 9 (14.3) | .86 |
| Unknown | 25 | 13 | 12 | |
| t(14;16), n (%) | 6 (4.6) | 3 (4.5) | 3 (4.8) | .94 |
| Unknown | 26 | 14 | 12 | |
| Bridging therapy, n (%) | 116 (74.4) | 63 (77.8) | 53 (70.7) | .31 |
| Refractory status | ||||
| Immunomodulatory agent, n (%) | 144 (92.3) | 75 (92.6) | 69 (92.0) | .89 |
| Proteasome inhibitor, n (%) | 140 (89.7) | 76 (93.8) | 64 (85.3) | .081‡ |
| Anti-CD38 antibody, n (%) | 146 (93.6) | 78 (96.3) | 68 (90.7) | .15 |
| Triple-refractory§, n (%) | 140 (89.7) | 77 (95.1) | 63 (84.0) | .023 |
| Penta-refractory||, n (%) | 62 (39.7) | 38 (46.9) | 24 (32.0) | .057‡ |
| Number of prior therapies | ||||
| Median (range) | 6 (4-18) | 6 (4-16) | 6 (4-18) | .85 |
| Average | 7.1 | 6.9 | 7.2 | |
| Time between diagnosis to CART infusion, y (average, n = 131) | 7.2 | 7 | 7.4 | .49 |
Bold indicates statistically significant difference between age groups, P < .05.
FLC, free light chain; IgA, immunoglobulin A; IgG, immunoglobulin G; IgM, immunoglobulin M; R-ISS, revised International Staging System.
High tumor burden defined by ≥50% clonal plasma cells in prelymphodepletion chemotherapy bone marrow biopsy.
As defined by the presence of del(17p), t(4;14) or t(14;16).
Borderline significance between age groups, P < .10.
Defined as refractory to ≥1 immunomodulatory drug, ≥1 proteasome inhibitor, and ≥1 anti-CD38 monoclonal antibody.
Penta-refractory defined as refractory to ≥2 immunomodulatory drugs, ≥2 proteasome inhibitors, and ≥1 anti-CD38 monoclonal antibody.