Table 1.
Patient characteristics at baseline, randomisation arm and response to therapy in the PET population in comparison with the general population.
| Characteristic | All FORTE (n = 474) | All pet (n = 109) | Excluded from subanalysis (n = 365) | P-value |
|---|---|---|---|---|
| Demographics | ||||
| Median age (IQR) | 57 (51–62) | 56 (51–61) | 57 (51–62) | 0.74 |
| Sex, female (%) | 212 (45) | 52 (48) | 160 (44) | 0.51 |
| Sex, male (%) | 262 (55) | 57 (52) | 205 (56) | |
| Disease characteristics, n (%) | ||||
| Isotype, BJ | 71 (15) | 18 (17) | 53 (15) | 0.62 |
| Isotype, IgA | 81 (17) | 17 (16) | 64 (18) | |
| Isotype, IgD | 3 (1) | 1 (1) | 2 (1) | |
| Isotype, IgG | 298 (63) | 66 (61) | 232 (64) | |
| Ns | 21 (4) | 7 (6) | 14 (4) | |
| Light chain, kappa | 295 (64) | 73 (68) | 222 (63) | 0.42 |
| Light chain, lambda | 165 (36) | 35 (32) | 130 (37) | |
| ISS, n (%) | ||||
| Stage I | 240 (51) | 55 (50) | 185 (51) | 0.93 |
| Stage II | 152 (32) | 34 (31) | 118 (32) | |
| Stage III | 82 (17) | 20 (18) | 62 (17) | |
| R–ISS, n (%) | ||||
| Stage I | 127 (31) | 40 (39) | 87 (28) | 0.08 |
| Stage II | 247 (59) | 52 (51) | 195 (62) | |
| Stage III | 42 (10) | 10 (10) | 32 (10) | |
| Missing | 58 | 7 | 51 | |
| LDH > ULN | 61 (13) | 12 (11) | 49 (14) | 0.62 |
| High-risk cytogenetics, n (%) | ||||
| del (13) | 204 (51) | 54 (56) | 150 (49) | 0.30 |
| del (17p13.1) | 61 (15) | 15 (15) | 46 (15) | 1 |
| del (1p32.3) | 44 (11) | 12 (13) | 32 (11) | 0.58 |
| t (4; 14) | 65 (16) | 8 (8) | 57 (18) | 0.017 |
| t (14; 16) | 21 (5) | 5 (5) | 16 (5) | 1 |
| t (11; 14) | 92 (23) | 15 (16) | 77 (25) | 0.069 |
| amp (1q21) | 185 (46) | 38 (40) | 147 (48) | 0.20 |
| High-risk cytogeneticsa | 133 (33) | 26 (26) | 107 (35) | 0.14 |
| Induction treatment randomisation (R1), n (%) | ||||
| KCd plus ASCT | 159 (34) | 29 (27) | 130 (36) | 0.15 |
| KRd12 | 157 (33) | 43 (39) | 114 (31) | |
| KRd plus ASCT | 158 (33) | 37 (34) | 121 (33) | |
| Pre-maintenance best response, n (%) | ||||
| sCR | 192 (41) | 69 (63) | 123 (34) | – |
| CR | 48 (10) | 7 (6) | 41 (11) | |
| VGPR | 157 (33) | 29 (24) | 128 (35) | |
| PR | 48 (10) | 4 (4) | 44 (12) | |
| SD | 9 (2) | 0 | 9 (2) | |
| PD | 6 (1) | 0 | 6 (2) | |
| Not evaluable | 14 (3) | 0 | 14 (4) | |
| Pre-maintenance MFC MRD status, n (%) | ||||
| Positive | 134 (28) | 23 (21) | 111 (30) | 0.0012 |
| Negative | 255 (54) | 83 (76) | 172 (47) | |
| Not evaluable | 85 (18)b | 3 (3) | 82 (22) | |
Abbreviations. amp, Amplification; ASCT, Autologous stem-cell transplantation; BJ, Bence–Jones; CR, Complete response; del, Deletion; EMD, Extra-medullary disease; Ig, Immunoglobulin; IQR, Interquartile range; ISS, International staging system; KCd, carfilzomib, cyclophosphamide and dexamethasone; KRd, carfilzomib, lenalidomide, and dexamethasone; MEL200, melphalan at 200 mg/m2; KRd plus ASCT, 4 KRd induction cycles, MEL200-ASCT, 4 KRd consolidation cycles; KRd12, 12 KRd cycles without ASCT; KCd plus ASCT, 4 KCd induction cycles, MEL200-ASCT, 4 KCd consolidation cycles; LDH, Lactate dehydrogenase; ULN, Upper limit of normal; MFC, Multiparameter flow cytometry; MRD, Minimal residual disease; N, n, number; Ns, Not specified; PD, Progression disease; PET, Positron emission tomography; PR, Partial response; R1, randomisation 1; R–ISS, Revised international staging system; sCR, stringent complete response; SD, Stable disease; t, translocation; VGPR, Very good partial response.
High risk was defined as the presence of one or more of the following cytogenetic abnormalities: del (17p) and/or t (4; 14) and/or t (14; 16).
45 patients were not evaluable because best response was either SD or PR, or because they were in PD; 40 patients were not evaluable because, despite VGPR response, their MRD status was unknown (MFC MRD assessment not available).