Cox proportional hazards model for PFS with MRD durability status as a covariate
| Variable . | MRD negativity sustained vs not sustained for ≥6 mo . | MRD negativity sustained vs not sustained for ≥12 mo . | ||
|---|---|---|---|---|
| HR (95% CI) | P | HR (95% CI) | P | |
| Univariate analysis | ||||
| Sustained MRD negativity (10−5) | 0.10 (0.06-0.18) | <.0001 | 0.09 (0.05-0.17) | <.0001 |
| Multivariate analysis 1 | ||||
| Sustained MRD negativity (10−5) | 0.12 (0.07-0.20) | <.0001 | 0.11 (0.05-0.21) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.55 (0.48-0.64) | <.0001 | 0.55 (0.47-0.64) | <.0001 |
| Multivariate analysis 2 | ||||
| Sustained MRD negativity (10−5) | 0.11 (0.07-0.19) | <.0001 | 0.10 (0.05-0.20) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.54 (0.47-0.63) | <.0001 | 0.54 (0.47-0.63) | <.0001 |
| Age (<75 vs ≥75 y) | 0.99 (0.85-1.15) | .8471 | 1.01 (0.87-1.17) | .9171 |
| ISS disease stage (I vs III) | 0.46 (0.38-0.57) | <.0001 | 0.48 (0.39-0.59) | <.0001 |
| ISS disease stage (II vs III) | 0.82 (0.70-0.96) | .0166 | 0.82 (0.70-0.97) | .0178 |
| Region (other vs NA/EU) | 0.72 (0.62-0.83) | <.0001 | 0.72 (0.62-0.84) | <.0001 |
| Variable . | MRD negativity sustained vs not sustained for ≥6 mo . | MRD negativity sustained vs not sustained for ≥12 mo . | ||
|---|---|---|---|---|
| HR (95% CI) | P | HR (95% CI) | P | |
| Univariate analysis | ||||
| Sustained MRD negativity (10−5) | 0.10 (0.06-0.18) | <.0001 | 0.09 (0.05-0.17) | <.0001 |
| Multivariate analysis 1 | ||||
| Sustained MRD negativity (10−5) | 0.12 (0.07-0.20) | <.0001 | 0.11 (0.05-0.21) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.55 (0.48-0.64) | <.0001 | 0.55 (0.47-0.64) | <.0001 |
| Multivariate analysis 2 | ||||
| Sustained MRD negativity (10−5) | 0.11 (0.07-0.19) | <.0001 | 0.10 (0.05-0.20) | <.0001 |
| Treatment (daratumumab-containing regimen vs SoC) | 0.54 (0.47-0.63) | <.0001 | 0.54 (0.47-0.63) | <.0001 |
| Age (<75 vs ≥75 y) | 0.99 (0.85-1.15) | .8471 | 1.01 (0.87-1.17) | .9171 |
| ISS disease stage (I vs III) | 0.46 (0.38-0.57) | <.0001 | 0.48 (0.39-0.59) | <.0001 |
| ISS disease stage (II vs III) | 0.82 (0.70-0.96) | .0166 | 0.82 (0.70-0.97) | .0178 |
| Region (other vs NA/EU) | 0.72 (0.62-0.83) | <.0001 | 0.72 (0.62-0.84) | <.0001 |
NA/EU, North America/Europe; SoC, standard of care.
Data are for a univariate and multivariate analysis of combined data from the MAIA and ALCYONE studies among patients who did and did not achieve sustained MRD negativity lasting ≥6 months or patients who did and did not achieve sustained MRD negativity lasting ≥12 months. The following variables were evaluated: sustained MRD negativity, treatment group, age, ISS disease stage, and region.