Baseline characteristics and treatment of patients who underwent apheresis for SOC cilta-cel manufacturing and those receiving cilta-cel infusion
| Characteristic . | N = 255 (apheresis) . | N = 236 (infused) . |
|---|---|---|
| n (%) or median (range) . | n (%) or median (range) . | |
| Age, y | 64 (30-84) | 64 (30-84) |
| Age ≥70 y | 65 (25%) | 62 (26%) |
| Male sex | 145 (57%) | 134 (57%) |
| Race and ethnicity | ||
| Non-Hispanic White | 190 (75%) | 177 (76%) |
| Hispanic (any race) | 20 (8%) | 19 (8%) |
| Black | 30 (12%) | 26 (11%) |
| Asian/Pacific Islander | 8 (3%) | 7 (3%) |
| American Indian/Alaskan Native | 1 (0.4%) | 1 (0.4%) |
| Other | 4 (1.6%) | 4 (1.7%) |
| Unknown | 2 | 2 |
| ECOG PS | At CAR T-cell evaluation | At lymphodepletion |
| 0-1 | 215 (92%) | 183 (89%) |
| 2-4 | 19 (8%) | 23 (11%) |
| Unknown | 21 | 30 |
| Myeloma subtype | ||
| Intact immunoglobulin | 184 (72%) | 170 (72%) |
| Light chain | 40 (16%) | 39 (17%) |
| Oligo/nonsecretory | 31 (12%) | 27 (11%) |
| R-ISS disease stage | ||
| I | 44 (27%) | 43 (28%) |
| II | 87 (53%) | 81 (53%) |
| III | 34 (21%) | 30 (19%) |
| Unknown | 90 | 82 |
| EMD | 66 (26%) | 60 (26%) |
| Unknown | 2 | 1 |
| High marrow burden, BMPCs ≥50% | 39 (19%) | 35 (18%) |
| Unknown | 46 | 39 |
| Cytogenetic abnormality | ||
| Any high-risk cytogenetics | 90 (40%) | 81 (39%) |
| Unknown | 32 | 30 |
| del(17p) | 57 (25%) | 52 (25%) |
| Unknown | 27 | 25 |
| t(4;14) | 31 (14%) | 28 (13%) |
| Unknown | 30 | 28 |
| t(14;16) | 10 (5%) | 8 (4%) |
| Unknown | 39 | 37 |
| PCL (active or history) | 17 (7%) | 13 (6%) |
| AL amyloidosis (active or history) | 8 (3%) | 8 (3%) |
| Bridging therapy | 195 (77%) | 184 (78%) |
| Unknown | 3 | 1 |
| Response to bridging therapy | ||
| PR or better | 44 (26%) | 44 (27%) |
| Unknown response | 27 | 23 |
| Prior therapies | ||
| Median prior antimyeloma therapies | 6 (2-18) | 6 (2-18) |
| Unknown | 1 | 0 |
| Prior autologous SCT | 216 (85%) | 200 (85%) |
| Unknown | 1 | 0 |
| Prior allogeneic SCT | 0 (0%) | 0 (0%) |
| Prior anti-BCMA therapy | 38 (15%) | 33 (14%) |
| Prior bispecific antibody (any target) | 12 (5%) | 10 (4%) |
| Refractory status | ||
| Immunomodulatory agent | 201 (79%) | 188 (80%) |
| Proteasome inhibitor | 197 (77%) | 184 (78%) |
| Anti-CD38 antibody | 209 (82%) | 196 (83%) |
| Triple-refractory | 176 (69%) | 163 (69%) |
| Penta-refractory | 75 (29%) | 70 (30%) |
| Was patient ineligible for the CARTITUDE-1 trial criteria at the time of leukapheresis | 144 (56%) | 128 (54%) |
| Ineligible for 1 criterion | 61 (24%) | 58 (25%) |
| Ineligible for ≥2 criteria | 83 (33%) | 70 (30%) |
| Organ dysfunction∗ (renal, cardiac, and hepatic) | 31 (13%) | 27 (12%) |
| Unknown | 9 | 8 |
| Creatinine clearance <40 mL/minute | 22 (9%) | 18 (8%) |
| Unknown | 1 | 0 |
| Prior anti-BCMA therapy | 38 (15%) | 33 (14%) |
| Cytopenias | 45 (18%) | 37 (16%) |
| Unknown | 1 | 1 |
| ECOG PS ≥2 | 28 (11%) | 25 (11%) |
| Unknown | 7 | 7 |
| History or presence of PCL, amyloidosis or POEMS | 28 (11%) | 24 (10%) |
| History of CNS myeloma and other CNS pathology | 12 (5%) | 12 (5%) |
| Lymphodepletion chemotherapy | ||
| Flu/Cy | 191 (81%) | |
| Bendamustine | 31 (13%) | |
| Cladribine + cyclophosphamide | 6 (3%) | |
| Cyclophosphamide only | 7 (3%) | |
| Unknown | 1 | |
| CAR T-cell dose (million cells per kg) | 0.6 (0.1-1.0) | |
| CAR T-cell dose ≥0.7 million cells per kg | 74 (33%) | |
| Unknown | 9 | |
| OOS/nonconforming product | 44 (19%) | |
| Time from apheresis to infusion | 70 d (36-275) |
| Characteristic . | N = 255 (apheresis) . | N = 236 (infused) . |
|---|---|---|
| n (%) or median (range) . | n (%) or median (range) . | |
| Age, y | 64 (30-84) | 64 (30-84) |
| Age ≥70 y | 65 (25%) | 62 (26%) |
| Male sex | 145 (57%) | 134 (57%) |
| Race and ethnicity | ||
| Non-Hispanic White | 190 (75%) | 177 (76%) |
| Hispanic (any race) | 20 (8%) | 19 (8%) |
| Black | 30 (12%) | 26 (11%) |
| Asian/Pacific Islander | 8 (3%) | 7 (3%) |
| American Indian/Alaskan Native | 1 (0.4%) | 1 (0.4%) |
| Other | 4 (1.6%) | 4 (1.7%) |
| Unknown | 2 | 2 |
| ECOG PS | At CAR T-cell evaluation | At lymphodepletion |
| 0-1 | 215 (92%) | 183 (89%) |
| 2-4 | 19 (8%) | 23 (11%) |
| Unknown | 21 | 30 |
| Myeloma subtype | ||
| Intact immunoglobulin | 184 (72%) | 170 (72%) |
| Light chain | 40 (16%) | 39 (17%) |
| Oligo/nonsecretory | 31 (12%) | 27 (11%) |
| R-ISS disease stage | ||
| I | 44 (27%) | 43 (28%) |
| II | 87 (53%) | 81 (53%) |
| III | 34 (21%) | 30 (19%) |
| Unknown | 90 | 82 |
| EMD | 66 (26%) | 60 (26%) |
| Unknown | 2 | 1 |
| High marrow burden, BMPCs ≥50% | 39 (19%) | 35 (18%) |
| Unknown | 46 | 39 |
| Cytogenetic abnormality | ||
| Any high-risk cytogenetics | 90 (40%) | 81 (39%) |
| Unknown | 32 | 30 |
| del(17p) | 57 (25%) | 52 (25%) |
| Unknown | 27 | 25 |
| t(4;14) | 31 (14%) | 28 (13%) |
| Unknown | 30 | 28 |
| t(14;16) | 10 (5%) | 8 (4%) |
| Unknown | 39 | 37 |
| PCL (active or history) | 17 (7%) | 13 (6%) |
| AL amyloidosis (active or history) | 8 (3%) | 8 (3%) |
| Bridging therapy | 195 (77%) | 184 (78%) |
| Unknown | 3 | 1 |
| Response to bridging therapy | ||
| PR or better | 44 (26%) | 44 (27%) |
| Unknown response | 27 | 23 |
| Prior therapies | ||
| Median prior antimyeloma therapies | 6 (2-18) | 6 (2-18) |
| Unknown | 1 | 0 |
| Prior autologous SCT | 216 (85%) | 200 (85%) |
| Unknown | 1 | 0 |
| Prior allogeneic SCT | 0 (0%) | 0 (0%) |
| Prior anti-BCMA therapy | 38 (15%) | 33 (14%) |
| Prior bispecific antibody (any target) | 12 (5%) | 10 (4%) |
| Refractory status | ||
| Immunomodulatory agent | 201 (79%) | 188 (80%) |
| Proteasome inhibitor | 197 (77%) | 184 (78%) |
| Anti-CD38 antibody | 209 (82%) | 196 (83%) |
| Triple-refractory | 176 (69%) | 163 (69%) |
| Penta-refractory | 75 (29%) | 70 (30%) |
| Was patient ineligible for the CARTITUDE-1 trial criteria at the time of leukapheresis | 144 (56%) | 128 (54%) |
| Ineligible for 1 criterion | 61 (24%) | 58 (25%) |
| Ineligible for ≥2 criteria | 83 (33%) | 70 (30%) |
| Organ dysfunction∗ (renal, cardiac, and hepatic) | 31 (13%) | 27 (12%) |
| Unknown | 9 | 8 |
| Creatinine clearance <40 mL/minute | 22 (9%) | 18 (8%) |
| Unknown | 1 | 0 |
| Prior anti-BCMA therapy | 38 (15%) | 33 (14%) |
| Cytopenias | 45 (18%) | 37 (16%) |
| Unknown | 1 | 1 |
| ECOG PS ≥2 | 28 (11%) | 25 (11%) |
| Unknown | 7 | 7 |
| History or presence of PCL, amyloidosis or POEMS | 28 (11%) | 24 (10%) |
| History of CNS myeloma and other CNS pathology | 12 (5%) | 12 (5%) |
| Lymphodepletion chemotherapy | ||
| Flu/Cy | 191 (81%) | |
| Bendamustine | 31 (13%) | |
| Cladribine + cyclophosphamide | 6 (3%) | |
| Cyclophosphamide only | 7 (3%) | |
| Unknown | 1 | |
| CAR T-cell dose (million cells per kg) | 0.6 (0.1-1.0) | |
| CAR T-cell dose ≥0.7 million cells per kg | 74 (33%) | |
| Unknown | 9 | |
| OOS/nonconforming product | 44 (19%) | |
| Time from apheresis to infusion | 70 d (36-275) |
High marrow burden was defined as ≥50% plasma cells in pre–cilta-cel bone marrow biopsy. High-risk cytogenetics include del(17p), t(4;14), and t(14;16). Penta-refractory disease includes refractory to lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab or isatuximab. Triple-refractory disease includes refractory to an immunomodulatory drug, proteasome inhibitor, and an anti-CD38 monoclonal antibody.
AL, light chain; BMPCs, bone marrow plasma cells; CNS, central nervous system; ECOG PS, ECOG performance status; SCT: stem cell transplantation.
Organ dysfunction definition are as follows: for renal insufficiency, creatinine clearance <40 mL/minute; cardiac dysfunction, left ventricular ejection fraction <45% or history of myocardial infarction in prior 6 months or stage III/IV congestive heart failure or clinically significant ventricular arrythmia; hepatic insufficiency, serum aspartate aminotransferase or alanine aminotransferase >3× upper limit of normal, serum total bilirubin >2× upper limit of normal. Cytopenias were defined as hemoglobin <8 g/dL, absolute neutrophil count <750/μL, and platelets <50 x 103/μL.