Potential exclusion from landmark clinical trials
| Clinical trials . | Clinical trial exclusion criteria and the number of patients potentially excluded (N = 75) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Exclusion criteria . | Total N (%) . | ||||||||
| Hb, g/dL . | ANC, 109/L . | Plt, 109/L . | Any hematologic exclusion criteria . | Renal function . | Liver function . | ECOG . | CNS disease . | ||
| Selinexor5 | <10∗ | <1.0∗ | <75∗ | 44 (59%) | GFR < 30 mL/min | T. Bili > 2 × ULN‡, ALT/AST > 3.0 × ULN‡ | >2 | Yes | 46 (61%) |
| Excluded N (%) | 36 (48%) | 19 (25%) | 30 (40%) | 2 (3%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Pola-BR3 | <9.0† | <1.5† | <75† | 44 (59%) | GFR < 40 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 2.5 × ULN‡ | > 2 | Yes | 48 (64%) |
| Excluded N (%) | 23 (31%) | 32 (43%) | 30 (40%) | 3 (4%) | 6 (8%) | 3 (5%) | 8 (11%) | ||
| Tafa-Len4 | None | <1.5† | <90† | 43 (57%) | GFR < 60 mL/min | T. Bili > 2.5 × ULN‡, ALT/AST > 3.0 × ULN‡ | >2 | Yes | 49 (65%) |
| Excluded N (%) | 0 | 32 (43%) | 34 (45%) | 13 (18%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Loncastuximab6 | None | <1.0 | <75 | 36 (48%) | GFR < 60 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 2.5 × ULN‡ | >2 | Yes | 45 (60%) |
| Excluded N (%) | 0 | 19 (25%) | 30 (40%) | 13 (18%) | 6 (8%) | 3 (5%) | 8 (11%) | ||
| Excluded from all the above trials N (%)§ | 0 | 19 (25%) | 30 (40%) | 36 (48%) | 2 (3%) | 5 (7%) | 3 (5%) | 8 (11%) | 39 (52%) |
| Clinical trials . | Clinical trial exclusion criteria and the number of patients potentially excluded (N = 75) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Exclusion criteria . | Total N (%) . | ||||||||
| Hb, g/dL . | ANC, 109/L . | Plt, 109/L . | Any hematologic exclusion criteria . | Renal function . | Liver function . | ECOG . | CNS disease . | ||
| Selinexor5 | <10∗ | <1.0∗ | <75∗ | 44 (59%) | GFR < 30 mL/min | T. Bili > 2 × ULN‡, ALT/AST > 3.0 × ULN‡ | >2 | Yes | 46 (61%) |
| Excluded N (%) | 36 (48%) | 19 (25%) | 30 (40%) | 2 (3%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Pola-BR3 | <9.0† | <1.5† | <75† | 44 (59%) | GFR < 40 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 2.5 × ULN‡ | > 2 | Yes | 48 (64%) |
| Excluded N (%) | 23 (31%) | 32 (43%) | 30 (40%) | 3 (4%) | 6 (8%) | 3 (5%) | 8 (11%) | ||
| Tafa-Len4 | None | <1.5† | <90† | 43 (57%) | GFR < 60 mL/min | T. Bili > 2.5 × ULN‡, ALT/AST > 3.0 × ULN‡ | >2 | Yes | 49 (65%) |
| Excluded N (%) | 0 | 32 (43%) | 34 (45%) | 13 (18%) | 5 (7%) | 3 (5%) | 8 (11%) | ||
| Loncastuximab6 | None | <1.0 | <75 | 36 (48%) | GFR < 60 mL/min | T. Bili > 1.5 × ULN‡, ALT/AST > 2.5 × ULN‡ | >2 | Yes | 45 (60%) |
| Excluded N (%) | 0 | 19 (25%) | 30 (40%) | 13 (18%) | 6 (8%) | 3 (5%) | 8 (11%) | ||
| Excluded from all the above trials N (%)§ | 0 | 19 (25%) | 30 (40%) | 36 (48%) | 2 (3%) | 5 (7%) | 3 (5%) | 8 (11%) | 39 (52%) |
Table depicting the exclusion criteria for each of the landmark clinical trials (Food and Drug Administration approved) and the number of patients who would be excluded based on each of these criteria and the total excluded for each trial.
ALT, alanine transaminase; AST, aspartate transaminase; GFR, glomerular filtration rate32; T. Bili, total serum bilirubin; ULN, upper limit of normality.
Growth factor use allowed, but red blood cell transfusion not allowed within 14 days.
Unless because of bone marrow involvement.
T. Bili ULN, 1.2 mg/dL; ALT ULN, 55 U/L; AST ULN, 48 U/L.
Last row shows number of patients who would be excluded from all the trials based on each and combined criteria.