Table 2. Hematologic and Kidney Responses.
| No. (%) of Patientsa | Between-Group Difference (95% CI), % |
P Value | ||
|---|---|---|---|---|
| High-Cutoff Hemodialysis (n = 46) |
Conventional Hemodialysis (n = 48) |
|||
| Primary Outcome | ||||
| Cumulative hemodialysis independence within 3 mo | 19 (41.3) | 16 (33.3) | 8.0 (−12.0 to 27.9) | .42 |
| Secondary Outcomes | ||||
| Cumulative hemodialysis independence within 6 mo | 26 (56.5) | 17 (35.4) | 21.1 (0.9 to 41.3) | .04 |
| Cumulative hemodialysis independence within 12 mo | 28 (60.9) | 18 (37.5) | 23.4 (3.2 to 43.5) | .02 |
| Time to hemodialysis independence, median (IQR), mo | 2.0 (0.4 to 5.7) | 1.0 (0.4 to 3.0) | .26 | |
| Alive without hemodialysis at 12 mo, No./total (%) | 24/37 (64.9) | 17/38 (44.7) | 20.2 (−2.6 to 42.9) | .15 |
| Hematologic response after first chemotherapy cycle | ||||
| Reduction in serum-free light chain, median (IQR), % | 89 (61 to 99) | 71 (22 to 91) | .02 | |
| Serum-free light chain level <500 mg/L | 20 (43.5) | 15 (31.2) | 12.3 (−7.7 to 32.1) | .29 |
| Hematologic response at 3 mo | ||||
| Overallb | 41 (89.1) | 30 (62.5) | 26.6 (9.8 to 43.4) | .003 |
| Very good partial or complete | 28 (60.9) | 21 (43.7) | 17.2 (−3.3 to 37.5) | .22 |
| Hematologic response at 6 mo | ||||
| Overallb | 36 (78.3) | 29 (60.4) | 17.9 (−0.8 to 36.5) | .06 |
| Very good partial or complete | 32 (69.6) | 23 (47.9) | 21.7 (1.8 to 41.5) | .03 |
| Serum-Free Light Chain Reduction With Hemodialysis | ||||
| Reduction after first hemodialysis session, median (IQR), % | ||||
| Overall | 68 (60 to 79) | 31 (9 to 49) | <.001 | |
| κ Light chain level | 77 (67 to 86) | 35 (19 to 48) | <.001 | |
| λ Light chain level | 63 (52 to 72) | 18 (6 to 56) | <.001 | |
| Reduction after third hemodialysis session, median (IQR), % | ||||
| Overall | 72 (64 to 80) | 34 (16 to 57) | <.001 | |
Abbreviation: IQR, interquartile range.
a
Unless otherwise indicated.
b
Indicates partial response, very good partial response, and complete response.