Table 3.
Univariate analysis and multivariable Cox regression analysis of pre-maintenance PET/CT parameters predicting for prolonged progression-free survival and overall survival.
| PFS (107 patients) | C-index | HR | 95% CI | P-value |
|---|---|---|---|---|
| CMR—Univariate analysis | 0.6244 | |||
| CMR: Neg vs Pos | 0.40 | (0.2–0.77) | 0.00654 | |
| CMR—Multivariate analysis | 0.7444 | |||
| CMR: Neg vs Pos | 0.31 | (0.14–0.66) | 0.00225 | |
| ISS: II/III vs 1 | 0.76 | (0.34–1.67) | 0.48,743 | |
| LDH: ≤ULN vs > ULN | 0.54 | (0.22–1.34) | 0.18,460 | |
| CA by FISH: Standard vs High riska | 0.31 | (0.13–0.70) | 0.00480 | |
| CA by FISH: NE vs High riska | 0.09 | (0.01–0.69) | 0.02081 | |
| R1: KRd12 vs KCd-ASCT | 1.77 | (0.71–4.43) | 0.22,255 | |
| R1: KRd plus ASCT vs KCd plus ASCT | 1.22 | (0.42–3.55) | 0.71,659 | |
| MFC MRD by ITT: Neg vs Pos | 1.04 | (0.45–2.38) | 0.92,713 | |
| Age: ≥60 vs < 60 | 0.80 | (0.36–1.80) | 0.59254 | |
| PET and MFC—Univariate analysis | 0.6125 | |||
| PET and MFC: Neg vs at least one Pos | 0.45 | (0.23–0.88) | 0.01979 | |
| PET and MFC—Multivariate analysis | 0.7302 | |||
| PET and MFC: Neg vs at least one Pos | 0.41 | (0.20–0.84) | 0.01516 | |
| ISS: II/III vs I | 0.88 | (0.42–1.86) | 0.73,879 | |
| LDH: ≤ULN vs > ULN | 0.50 | (0.20–1.23) | 0.13,185 | |
| LDH: NE vs > ULN | 1.05 | (0.11–10.54) | 0.96,431 | |
| CA by FISH: Standard vs High riska | 0.38 | (0.17–0.83) | 0.01516 | |
| CA by FISH: NE vs High riska | 0.11 | (0.01–0.90) | 0.03909 | |
| R1: KRd12 vs KCd plus ASCT | 1.79 | (0.71–4.50) | 0.21,936 | |
| R1: KRd plus ASCT vs KCd plus ASCT | 1.21 | (0.42–3.46) | 0.72,191 | |
| Age: ≥60 vs < 60 | 0.76 | (0.35–1.68) | 0.50093 | |
| OS (109 patients) | HR | 95% CI | p-value | |
| CMR—Univariate analysis | 0.6006 | |||
| CMR: Neg vs Pos | 0.44 | (0.17–1.15) | 0.09387 | |
| CMR—Multivariate analysis | 0.8200 | |||
| CMR: Neg vs Pos | 0.17 | (0.05–0.56) | 0.00373 | |
| ISS: II/III vs I | 0.57 | (0.16–2.08) | 0.39,713 | |
| LDH: ≤ULN vs > ULN | 0.18 | (0.06–0.61) | 0.00548 | |
| LDH: NE vs > ULN | 1.09 | (0.10–12.24) | 0.94,684 | |
| CA by FISH: Standard vs High riska | 0.10 | (0.03–0.41) | 0.00114 | |
| CA by FISH: NE vs High riska | 0.17 | (0.02–1.60) | 0.12,193 | |
| R1: KRd12 vs KCd plus ASCT | 1.06 | (0.25–4.53) | 0.93,899 | |
| R1: KRd plus ASCT vs KCd plus ASCT | 0.70 | (0.13–3.76) | 0.67,646 | |
| MFC MRD by ITT: NEG vs POS | 1.01 | (0.28–3.64) | 0.98,354 | |
| Age: ≥60 vs < 60 | 2.47 | (0.69–8.88) | 0.16669 | |
| PET and MFC—Univariate analysis | 0.574 | |||
| PET and MFC (Neg vs at least one Pos) | 0.56 | (0.21–1.44) | 0.22,786 | |
| PET and MFC—Multivariate analysis | 0.8072 | |||
| PET and MFC (Neg vs at least one Pos) | 0.29 | (0.09–0.96) | 0.04239 | |
| ISS: II/III vs I | 0.71 | (0.21–2.40) | 0.58,667 | |
| LDH: ≤ULN vs > ULN | 0.19 | (0.06–0.63) | 0.00658 | |
| LDH: NE vs > ULN | 0.95 | (0.08–10.60) | 0.96,542 | |
| CA by FISH: Standard vs High riska | 0.17 | (0.05–0.53) | 0.00247 | |
| CA by FISH: NE vs High riska | 0.29 | (0.03–2.40) | 0.24,893 | |
| R1: KRd12 vs KCd plus ASCT | 1.03 | (0.24–4.44) | 0.96,423 | |
| R1: KRd plus ASCT vs KCd plus ASCT | 0.79 | (0.16–3.89) | 0.77,375 | |
| Age: ≥60 vs < 60 | 2.04 | (0.61–6.84) | 0.25015 | |
Abbreviations. ASCT, Autologous stem-cell transplantation; CA, Cytogenetic abnormalities; CI, Confidence interval; CMR, Complete metabolic response; FISH, Fluorescence in situ hybridisation; HR, Hazard ratio; ISS, International staging system stage; KCd, carfilzomib-cyclophosphamide-dexamethasone; MEL200, melphalan at 200 mg/m2; KCd plus ASCT, 4 KCd induction cycles, MEL200-ASCT, 4 KCd consolidation cycles; KRd, carfilzomib-lenalidomide-dexamethasone; KRd12, 12 KRd cycles without ASCT; KRd plus ASCT, 4 KRd induction cycles, MEL200-ASCT, 4 KRd consolidation cycles; LDH, Lactate dehydrogenase; NE, Not estimable; Neg, Negative; MFC, Multiparameter flow cytometry; OS, Overall survival; PET/CT, Positron emission tomography/computed tomography; PFS, Progression-free survival; Pos, Positive; R1, first randomisation (induction-intensification-consolidation treatment); ULN, Upper limit of normal.
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).