Cox analysis of the impact of proposed response and progression criteria on renal survival (6-month landmark analysis)
| Criteria . | Definition . | Testing cohort (n = 301) . | Validation cohort (n = 171) . | ||
|---|---|---|---|---|---|
| HR (95% CI) . | P . | HR (95% CI) . | P . | ||
| Renal progression | ≥25% decrease in eGFR | 4.56 (2.44-8.52) | <.001 | 4.74 (2.64-8.50) | <.001 |
| Renal response | ≥30% decrease in proteinuria or drop of proteinuria below 0.5 g/24 h in the absence of renal progression | 0.15 (0.05-0.49) | <.001 | 0.25 (0.06-0.98) | .039 |
| Target hematologic response | VGPR (dFLC <40 mg/L in patients with baseline dFLC ≥50 mg/L) or CR (negative serum and urine immunofixation and normal FLC ratio) | 0.47 (0.25-0.87) | .014 | 0.24 (0.13-0.48) | <.001 |
| Criteria . | Definition . | Testing cohort (n = 301) . | Validation cohort (n = 171) . | ||
|---|---|---|---|---|---|
| HR (95% CI) . | P . | HR (95% CI) . | P . | ||
| Renal progression | ≥25% decrease in eGFR | 4.56 (2.44-8.52) | <.001 | 4.74 (2.64-8.50) | <.001 |
| Renal response | ≥30% decrease in proteinuria or drop of proteinuria below 0.5 g/24 h in the absence of renal progression | 0.15 (0.05-0.49) | <.001 | 0.25 (0.06-0.98) | .039 |
| Target hematologic response | VGPR (dFLC <40 mg/L in patients with baseline dFLC ≥50 mg/L) or CR (negative serum and urine immunofixation and normal FLC ratio) | 0.47 (0.25-0.87) | .014 | 0.24 (0.13-0.48) | <.001 |
CR, complete response; dFLC, difference between involved (amyloidogenic) and uninvolved free light chain.