Patient and disease characteristics
| . | Overall N = 158 . | Non-CTX n = 82 . | Intermediate CTX n = 55 . | Intensive CTX n = 21 . | P value . |
|---|---|---|---|---|---|
| Age, y | |||||
| Median (Q1, Q3) | 64 (57, 70) | 64 (59, 70) | 65 (57, 71) | 59 (50, 65) | .043 |
| <70, n (%) | 117 (74) | 59 (72) | 39 (71) | 19 (90) | .2 |
| ≥70, n (%) | 41 (26) | 23 (28) | 16 (29) | 2 (9.5) | |
| Sex, n (%) | .7 | ||||
| Male | 103 (65) | 54 (66) | 37 (67) | 12 (57) | |
| Female | 55 (35) | 28 (34) | 18 (33) | 9 (43) | |
| Race, n (%) | .7 | ||||
| Asian | 3 (1.9) | 1 (1.2) | 2 (3.6) | 0 (0) | |
| Black or African American | 6 (3.8) | 4 (4.9) | 1 (1.8) | 1 (4.8) | |
| White | 144 (91) | 75 (91) | 49 (89) | 20 (95) | |
| Other | 5 (3.2) | 2 (2.4) | 3 (5.5) | 0 (0) | |
| Ethnicity, n (%) | .7 | ||||
| Hispanic or Latino | 3 (1.9) | 1 (1.2) | 2 (3.6) | 0 (0) | |
| Not Hispanic or Latino | 155 (98) | 81 (99) | 53 (96) | 21 (100) | |
| ECOG PS score,∗ n (%) | .6 | ||||
| 0-1 | 136 (95) | 70 (93) | 47 (96) | 19 (100) | |
| 2-3 | 7 (4.9) | 5 (6.7) | 2 (4.1) | 0 (0) | |
| Unknown | 15 | 7 | 6 | 2 | |
| Time from initial diagnosis to CAR-T therapy, median (Q1, Q3), y | 6.4 (4.1, 8.6) | 6.3 (4.4, 8.7) | 6.7 (4.1, 8.9) | 6.3 (2.8, 8.3) | .6 |
| ISS stage,∗ n (%) | .4 | ||||
| I | 80 (59) | 39 (55) | 29 (63) | 12 (63) | |
| II | 45 (33) | 28 (39) | 11 (24) | 6 (32) | |
| III | 11 (8.1) | 4 (5.6) | 6 (13) | 1 (5.3) | |
| Unknown | 22 | 11 | 9 | 2 | |
| R-ISS,∗ n (%) | .014 | ||||
| I | 32 (24) | 10 (14) | 19 (41) | 3 (15) | |
| II | 97 (71) | 56 (80) | 25 (54) | 16 (80) | |
| III | 7 (5.1) | 4 (5.7) | 2 (4.3) | 1 (5.0) | |
| Unknown | 22 | 12 | 9 | 1 | |
| Extramedullary disease,∗ n (%) | .4 | ||||
| No | 90 (58) | 50 (63) | 28 (51) | 12 (57) | |
| Yes | 65 (42) | 29 (37) | 27 (49) | 9 (43) | |
| Unknown | 3 | 3 | 0 | 0 | |
| Extraosseous disease,∗ n (%) | .1 | ||||
| No | 117 (75) | 63 (80) | 42 (76) | 12 (57) | |
| Yes | 38 (25) | 16 (20) | 13 (24) | 9 (43) | |
| Unknown | 3 | 3 | 0 | 0 | |
| Cytogenetics, n (%) | .2 | ||||
| Standard risk | 90 (60) | 43 (57) | 37 (70) | 10 (50) | |
| High risk | 59 (40) | 33 (43) | 16 (30) | 10 (50) | |
| del(17p) | 38 (26) | 22 (29) | 11 (21) | 5 (25) | .6 |
| t(4;14) | 22 (15) | 13 (17) | 4 (7.5) | 5 (25) | .13 |
| t(14;16) | 5 (3.4) | 2 (2.6) | 1 (1.9) | 2 (10) | .3 |
| +1q | 68 (46) | 32 (42) | 28 (53) | 8 (40) | .4 |
| Unknown | 9 | 6 | 2 | 1 | |
| Bone marrow burden,† n (%) | .6 | ||||
| <50% | 76 (79) | 40 (77) | 28 (85) | 8 (73) | |
| ≥50% | 20 (21) | 12 (23) | 5 (15) | 3 (27) | |
| Unknown | 62 | 30 | 22 | 10 | |
| Previous therapy lines, median (Q1, Q3) | 5 (5, 7) | 5 (4, 7) | 5 (5, 6) | 6 (5, 7) | .6 |
| Previous therapies, n (%) | |||||
| Autologous SCT | 144 (91) | 76 (93) | 50 (91) | 18 (86) | .6 |
| Allogeneic SCT | 12 (7.6) | 4 (4.9) | 4 (7.3) | 4 (19) | .12 |
| BCMA-targeted therapy | 25 (16) | 15 (18) | 5 (9.1) | 5 (24) | .2 |
| Belantamab | 24 (15) | 15 (18) | 4 (7) | 5 (24) | .1 |
| Bispecific T-cell engager | 7 (4.4) | 4 (4.9) | 2 (3.6) | 1 (4.8) | > .9 |
| Talquetamab | 5 (3.2) | 4 (4.9) | 1 (1.8) | 0 (0) | .14 |
| Teclistamab | 2 (1.3) | 0 (0) | 1 (1.8) | 1 (4.8) | |
| CAR-T therapy | 1 (0.6) | 0 (0) | 1 (1.8)‡ | 0 (0) | .5 |
| Triple-class refractory,§ n (%) | .2 | ||||
| No | 28 (18) | 11 (14) | 14 (25) | 3 (14) | |
| Yes | 129 (82) | 70 (86) | 41 (75) | 18 (86) | |
| Unknown | 1 | 1 | 0 | 0 | |
| Penta-drug exposed,|| n (%) | .8 | ||||
| No | 31 (20) | 16 (20) | 12 (22) | 3 (14) | |
| Yes | 127 (80) | 66 (80) | 43 (78) | 18 (86) | |
| Penta-drug refractory,|| n (%) | .5 | ||||
| No | 111 (72) | 57 (71) | 41 (76) | 13 (62) | |
| Yes | 44 (28) | 23 (29) | 13 (24) | 8 (38) | |
| Unknown | 3 | 2 | 1 | 0 | |
| Center, n (%) | .004 | ||||
| Germany | 92 (58) | 38 (46) | 41 (75) | 13 (62) | |
| United States | 66 (42) | 44 (54) | 14 (25) | 8 (38) | |
| CAR-T product, n (%) | .066 | ||||
| Cilta-cel | 22 (14) | 11 (13) | 11 (20) | 0 (0) | |
| Ide-cel | 136 (86) | 71 (87) | 44 (80) | 21 (100) | |
| Out-of-specification CAR-T product,¶ n (%) | .7 | ||||
| No | 151 (96) | 78 (96) | 52 (95) | 21 (100) | |
| Yes | 6 (3.8) | 3 (3.7) | 3 (5.5) | 0 (0) | |
| Unknown | 1 | 1 | 0 | 0 | |
| Lymphodepletion, n (%) | .3 | ||||
| Bendamustine | 5 (3.2) | 2 (2.4) | 1 (1.8) | 2 (9.5) | |
| Fludarabine/cyclophosphamide | 153 (97) | 80 (98) | 54 (98) | 19 (90) | |
| Vein-to-vein time,# median (Q1, Q3), d | 53 (46, 63)∗∗ | 49 (43, 60) | 58 (48, 69) | 51 (48, 56) | .022 |
| . | Overall N = 158 . | Non-CTX n = 82 . | Intermediate CTX n = 55 . | Intensive CTX n = 21 . | P value . |
|---|---|---|---|---|---|
| Age, y | |||||
| Median (Q1, Q3) | 64 (57, 70) | 64 (59, 70) | 65 (57, 71) | 59 (50, 65) | .043 |
| <70, n (%) | 117 (74) | 59 (72) | 39 (71) | 19 (90) | .2 |
| ≥70, n (%) | 41 (26) | 23 (28) | 16 (29) | 2 (9.5) | |
| Sex, n (%) | .7 | ||||
| Male | 103 (65) | 54 (66) | 37 (67) | 12 (57) | |
| Female | 55 (35) | 28 (34) | 18 (33) | 9 (43) | |
| Race, n (%) | .7 | ||||
| Asian | 3 (1.9) | 1 (1.2) | 2 (3.6) | 0 (0) | |
| Black or African American | 6 (3.8) | 4 (4.9) | 1 (1.8) | 1 (4.8) | |
| White | 144 (91) | 75 (91) | 49 (89) | 20 (95) | |
| Other | 5 (3.2) | 2 (2.4) | 3 (5.5) | 0 (0) | |
| Ethnicity, n (%) | .7 | ||||
| Hispanic or Latino | 3 (1.9) | 1 (1.2) | 2 (3.6) | 0 (0) | |
| Not Hispanic or Latino | 155 (98) | 81 (99) | 53 (96) | 21 (100) | |
| ECOG PS score,∗ n (%) | .6 | ||||
| 0-1 | 136 (95) | 70 (93) | 47 (96) | 19 (100) | |
| 2-3 | 7 (4.9) | 5 (6.7) | 2 (4.1) | 0 (0) | |
| Unknown | 15 | 7 | 6 | 2 | |
| Time from initial diagnosis to CAR-T therapy, median (Q1, Q3), y | 6.4 (4.1, 8.6) | 6.3 (4.4, 8.7) | 6.7 (4.1, 8.9) | 6.3 (2.8, 8.3) | .6 |
| ISS stage,∗ n (%) | .4 | ||||
| I | 80 (59) | 39 (55) | 29 (63) | 12 (63) | |
| II | 45 (33) | 28 (39) | 11 (24) | 6 (32) | |
| III | 11 (8.1) | 4 (5.6) | 6 (13) | 1 (5.3) | |
| Unknown | 22 | 11 | 9 | 2 | |
| R-ISS,∗ n (%) | .014 | ||||
| I | 32 (24) | 10 (14) | 19 (41) | 3 (15) | |
| II | 97 (71) | 56 (80) | 25 (54) | 16 (80) | |
| III | 7 (5.1) | 4 (5.7) | 2 (4.3) | 1 (5.0) | |
| Unknown | 22 | 12 | 9 | 1 | |
| Extramedullary disease,∗ n (%) | .4 | ||||
| No | 90 (58) | 50 (63) | 28 (51) | 12 (57) | |
| Yes | 65 (42) | 29 (37) | 27 (49) | 9 (43) | |
| Unknown | 3 | 3 | 0 | 0 | |
| Extraosseous disease,∗ n (%) | .1 | ||||
| No | 117 (75) | 63 (80) | 42 (76) | 12 (57) | |
| Yes | 38 (25) | 16 (20) | 13 (24) | 9 (43) | |
| Unknown | 3 | 3 | 0 | 0 | |
| Cytogenetics, n (%) | .2 | ||||
| Standard risk | 90 (60) | 43 (57) | 37 (70) | 10 (50) | |
| High risk | 59 (40) | 33 (43) | 16 (30) | 10 (50) | |
| del(17p) | 38 (26) | 22 (29) | 11 (21) | 5 (25) | .6 |
| t(4;14) | 22 (15) | 13 (17) | 4 (7.5) | 5 (25) | .13 |
| t(14;16) | 5 (3.4) | 2 (2.6) | 1 (1.9) | 2 (10) | .3 |
| +1q | 68 (46) | 32 (42) | 28 (53) | 8 (40) | .4 |
| Unknown | 9 | 6 | 2 | 1 | |
| Bone marrow burden,† n (%) | .6 | ||||
| <50% | 76 (79) | 40 (77) | 28 (85) | 8 (73) | |
| ≥50% | 20 (21) | 12 (23) | 5 (15) | 3 (27) | |
| Unknown | 62 | 30 | 22 | 10 | |
| Previous therapy lines, median (Q1, Q3) | 5 (5, 7) | 5 (4, 7) | 5 (5, 6) | 6 (5, 7) | .6 |
| Previous therapies, n (%) | |||||
| Autologous SCT | 144 (91) | 76 (93) | 50 (91) | 18 (86) | .6 |
| Allogeneic SCT | 12 (7.6) | 4 (4.9) | 4 (7.3) | 4 (19) | .12 |
| BCMA-targeted therapy | 25 (16) | 15 (18) | 5 (9.1) | 5 (24) | .2 |
| Belantamab | 24 (15) | 15 (18) | 4 (7) | 5 (24) | .1 |
| Bispecific T-cell engager | 7 (4.4) | 4 (4.9) | 2 (3.6) | 1 (4.8) | > .9 |
| Talquetamab | 5 (3.2) | 4 (4.9) | 1 (1.8) | 0 (0) | .14 |
| Teclistamab | 2 (1.3) | 0 (0) | 1 (1.8) | 1 (4.8) | |
| CAR-T therapy | 1 (0.6) | 0 (0) | 1 (1.8)‡ | 0 (0) | .5 |
| Triple-class refractory,§ n (%) | .2 | ||||
| No | 28 (18) | 11 (14) | 14 (25) | 3 (14) | |
| Yes | 129 (82) | 70 (86) | 41 (75) | 18 (86) | |
| Unknown | 1 | 1 | 0 | 0 | |
| Penta-drug exposed,|| n (%) | .8 | ||||
| No | 31 (20) | 16 (20) | 12 (22) | 3 (14) | |
| Yes | 127 (80) | 66 (80) | 43 (78) | 18 (86) | |
| Penta-drug refractory,|| n (%) | .5 | ||||
| No | 111 (72) | 57 (71) | 41 (76) | 13 (62) | |
| Yes | 44 (28) | 23 (29) | 13 (24) | 8 (38) | |
| Unknown | 3 | 2 | 1 | 0 | |
| Center, n (%) | .004 | ||||
| Germany | 92 (58) | 38 (46) | 41 (75) | 13 (62) | |
| United States | 66 (42) | 44 (54) | 14 (25) | 8 (38) | |
| CAR-T product, n (%) | .066 | ||||
| Cilta-cel | 22 (14) | 11 (13) | 11 (20) | 0 (0) | |
| Ide-cel | 136 (86) | 71 (87) | 44 (80) | 21 (100) | |
| Out-of-specification CAR-T product,¶ n (%) | .7 | ||||
| No | 151 (96) | 78 (96) | 52 (95) | 21 (100) | |
| Yes | 6 (3.8) | 3 (3.7) | 3 (5.5) | 0 (0) | |
| Unknown | 1 | 1 | 0 | 0 | |
| Lymphodepletion, n (%) | .3 | ||||
| Bendamustine | 5 (3.2) | 2 (2.4) | 1 (1.8) | 2 (9.5) | |
| Fludarabine/cyclophosphamide | 153 (97) | 80 (98) | 54 (98) | 19 (90) | |
| Vein-to-vein time,# median (Q1, Q3), d | 53 (46, 63)∗∗ | 49 (43, 60) | 58 (48, 69) | 51 (48, 56) | .022 |
Significant P values are set in boldface.
ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; Q1, lower quartile; Q3, upper quartile; R-ISS, Revised International Staging System; SCT, stem cell transplant.
Determined before lymphodepletion.
Last bone marrow status determined within 90 days before CAR-T therapy.
Allogeneic anti-BCMA CAR-T therapy.
Refractory to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Exposed/refractory to lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab.
Refers to the final quality of the CAR-T product administered to the patient.
Refers to the time between (final) leukapheresis and CAR-T infusion.
Vein-to-vein time (median [Q1, Q3]) depending on CAR-T product: 49 days (45, 58) for ide-cel, and 69 days (63, 84) for cilta-cel (P < .001).