Time-varying Cox proportional hazard model for PFS
| Variable . | HR (95% CI) . | P value . |
|---|---|---|
| RRMM and TIE NDMM | ||
| Univariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.17 (0.12-0.24) | <.0001 |
| Multivariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.20 (0.14-0.29) | <.0001 |
| Disease setting (NDMM vs RRMM) | 0.45 (0.39-0.52) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.48 (0.43-0.54) | <.0001 |
| Age | 1.00 (0.99-1.01) | .9619 |
| ISS disease stage (II vs I) | 1.76 (1.52-2.03) | <.0001 |
| ISS disease stage (III vs I) | 1.94 (1.64-2.30) | <.0001 |
| Baseline renal function (>60 mL/min vs ≤60 mL/min) | 1.00 (0.87-1.14) | .9449 |
| Cytogenetic risk (high vs standard) | 1.53 (1.30-1.79) | <.0001 |
| RRMM ≤2 PL and TIE NDMM | ||
| Univariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.16 (0.11-0.24) | <.0001 |
| Multivariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.19 (0.13-0.29) | <.0001 |
| Disease setting (NDMM vs RRMM) | 0.46 (0.39-0.53) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.46 (0.40-0.52) | <.0001 |
| Age | 1.00 (0.99-1.01) | .7395 |
| ISS disease stage (II vs I) | 1.80 (1.54-2.11) | <.0001 |
| ISS disease stage (III vs I) | 1.93 (1.61-2.31) | <.0001 |
| Baseline renal function (>60 mL/min vs ≤60 mL/min) | 1.02 (0.89-1.18) | .7601 |
| Cytogenetic risk (high vs standard) | 1.64 (1.38-1.94) | <.0001 |
| Variable . | HR (95% CI) . | P value . |
|---|---|---|
| RRMM and TIE NDMM | ||
| Univariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.17 (0.12-0.24) | <.0001 |
| Multivariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.20 (0.14-0.29) | <.0001 |
| Disease setting (NDMM vs RRMM) | 0.45 (0.39-0.52) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.48 (0.43-0.54) | <.0001 |
| Age | 1.00 (0.99-1.01) | .9619 |
| ISS disease stage (II vs I) | 1.76 (1.52-2.03) | <.0001 |
| ISS disease stage (III vs I) | 1.94 (1.64-2.30) | <.0001 |
| Baseline renal function (>60 mL/min vs ≤60 mL/min) | 1.00 (0.87-1.14) | .9449 |
| Cytogenetic risk (high vs standard) | 1.53 (1.30-1.79) | <.0001 |
| RRMM ≤2 PL and TIE NDMM | ||
| Univariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.16 (0.11-0.24) | <.0001 |
| Multivariate analysis | ||
| Response group (≥CR + MRD negative vs ≤VGPR or MRD positive) | 0.19 (0.13-0.29) | <.0001 |
| Disease setting (NDMM vs RRMM) | 0.46 (0.39-0.53) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.46 (0.40-0.52) | <.0001 |
| Age | 1.00 (0.99-1.01) | .7395 |
| ISS disease stage (II vs I) | 1.80 (1.54-2.11) | <.0001 |
| ISS disease stage (III vs I) | 1.93 (1.61-2.31) | <.0001 |
| Baseline renal function (>60 mL/min vs ≤60 mL/min) | 1.02 (0.89-1.18) | .7601 |
| Cytogenetic risk (high vs standard) | 1.64 (1.38-1.94) | <.0001 |
Data are shown for univariate and multivariate analyses using combined data from all RRMM and TIE NDMM patients in POLLUX, CASTOR, ALCYONE, and MAIA (RRMM and TIE NDMM) and among patients with RRMM with ≤2 PL from POLLUX and CASTOR and TIE NDMM from ALCYONE and MAIA (RRMM ≤2 PL and TIE NDMM). The following variables were evaluated: MRD negativity status with best response, disease setting, treatment, age, ISS disease stage, baseline renal function, and cytogenetic risk. RRMM and TIE NDMM patients with missing data for baseline renal function (POLLUX, n = 9; CASTOR, n = 20; ALCYONE, n = 0; MAIA, n = 0; total n = 29) or cytogenetic risk (POLLUX, n = 130; CASTOR, n = 142; ALCYONE, n = 90; MAIA, n = 95; total n = 457) were excluded from the multivariate model. RRMM ≤2 PL and TIE NDMM patients with missing data for baseline renal function (POLLUX, n = 8; CASTOR, n = 14; ALCYONE, n = 0; MAIA, n = 0; total n = 22) or cytogenetic risk (POLLUX, n = 108; CASTOR, n = 111; ALCYONE, n = 90; MAIA, n = 95; total n = 404) were excluded from the multivariate model.
SoC, standard of care.