Table 3.
Baseline and post-infusion characteristics in patients with and without MNTs in CARTITUDE-1.
| Baseline characteristic | MNTs | |
|---|---|---|
| No (n = 92) | Yes (n = 5) | |
| Age, years; n (%) | ||
| <65 | 59 (64.1) | 3 (60.0) |
| 65–75 | 26 (28.3) | 1 (20.0) |
| >75 | 7 (7.6) | 1 (20.0) |
| Sex, n (%) | ||
| Female | 40 (43.5) | 0 |
| Male | 52 (56.5) | 5 (100.0) |
| Race, n (%) | ||
| White | 64 (69.6) | 5 (100.0) |
| African American | 17 (18.5) | 0 |
| Other | 11 (12.0) | 0 |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 6 (6.5) | 0 |
| Non-Hispanic or Latino | 80 (87.0) | 5 (100.0) |
| Not reported | 6 (6.5) | 0 |
| ECOG PS scorea, n (%) | ||
| 0 | 36 (39.1) | 3 (60.0) |
| 1 | 52 (56.5) | 2 (40.0) |
| 2 | 4 (4.3) | 0 |
| Tumor burden categoryb, n (%) | ||
| High | 13 (14.1) | 3 (60.0) |
| Intermediate | 21 (22.8) | 1 (20.0) |
| Low | 58 (63.0) | 1 (20.0) |
| Type of myeloma, n (%) | ||
| IgG | 55 (59.8) | 2 (40.0) |
| Non-IgG | 37 (40.2) | 3 (60.0) |
| Measurable disease type, n (%) | ||
| Serum only, serum and urine | 51 (55.4) | 4 (80.0) |
| Urine only, FLC, not evaluable | 41 (44.6) | 1 (20.0)c |
| Extramedullary plasmacytoma, n (%) | ||
| No | 80 (87.0) | 4 (80.0) |
| Yes | 12 (13.0) | 1 (20.0) |
| Bone-based plasmacytoma, n (%) | ||
| No | 87 (94.6) | 4 (80.0) |
| Yes | 5 (5.4) | 1 (20.0) |
| Number of prior lines of therapy, n (%) | ||
| 3–5 | 46 (50.0) | 3 (60.0) |
| ≥6 | 46 (50.0) | 2 (40.0) |
| Prior radiotherapy including brain area, n (%) | ||
| No | 84 (91.3) | 5 (100.0) |
| Yes | 8 (8.7) | 0 |
| Prior bridging therapy, n (%) | ||
| No | 24 (26.1) | 0 |
| Yes | 68 (73.9) | 5 (100.0) |
| Type of prior bridging therapy, n (%) | ||
| Daratumumab | ||
| No | 78 (84.8) | 4 (80.0) |
| Yes | 14 (15.2) | 1 (20.0) |
| Lenalidomide | ||
| No | 86 (93.5) | 5 (100.0) |
| Yes | 6 (6.5) | 0 |
| Post-infusion characteristic | ||
| Total CAR + viable T-cells infused (×106), n (%) | ||
| <median value | 46 (50.0) | 2 (40.0) |
| ≥ median value | 46 (50.0) | 3 (60.0) |
| High cell expansion/persistenced, n (%) | ||
| No | 84 (91.3) | 1 (20.0) |
| Yes | 8 (8.7) | 4 (80.0) |
| CRS, n (%) | ||
| No | 5 (5.4) | 0 |
| Yes | 87 (94.6) | 5 (100.0) |
| CRS maximum toxicity grade, n (%) | ||
| Grade <2 | 54 (58.7) | 0 |
| Grade ≥2 | 38 (41.3) | 5 (100.0) |
| ICANS, n (%) | ||
| No | 80 (87.0) | 1 (20.0) |
| Yes | 12 (13.0) | 4 (80.0) |
CAR chimeric antigen receptor, Cmax maximum CAR transgene systemic level, CRS cytokine release syndrome, ECOG PS Eastern Cooperative Oncology Group performance status, FLC free light chain, ICANS immune effector cell-associated neurotoxicity syndrome, IgG immunoglobulin G, MNTs movement and neurocognitive treatment-emergent adverse events.
aThe last non-missing ECOG PS score on or prior to date of cilta-cel infusion was used; all patients met the inclusion criteria of ECOG PS score of 0 or 1 during screening.
bPatients were categorized as having high tumor burden at baseline (prior to lymphodepletion) if they met any of the following: plasma cell infiltrate in the bone marrow ≥80%, serum M-spike ≥5 g/dL, serum free light chain ≥5000 mg/L. Those with low tumor burden had all of the following: plasma cell infiltrate in the bone marrow <50%, serum M-spike <3 g/dL, and serum free light chain <3000 mg/L. Patients who did not fit either criterion were categorized as having intermediate tumor burden.
cPatient was FLC-evaluable.
dPatients with peripheral blood CAR T cells Cmax of >1000 cells/μL and CAR T cells >300 cells/μL at Day 56.