Hematologic and renal response
| . | dFLC ≥50 mg/L . | dFLC <50 mg/L . | P* . |
|---|---|---|---|
| Hematologic response | |||
| 3 mo | n = 565 | n = 85 | |
| aCR | 34 (6) | 20 (24) | <.001 |
| Low-dFLC PR | n.a. | 18 (21) | n.a. |
| VGPR | 137 (24 | n.a. | n.a. |
| PR | 132 (23) | n.a. | n.a. |
| No response | 144 (26) | 41 (48) | .001 |
| Early death | 118 (21) | 6 (7) | .002 |
| 6 mo | n = 554 | n = 88 | |
| aCR | 48 (9) | 34 (39) | <.001 |
| Low-dFLC PR | n.a. | 14 (16) | n.a. |
| VGPR | 130 (23) | n.a. | n.a. |
| PR | 112 (20) | n.a. | n.a. |
| No response | 77 (14) | 31 (35) | .001 |
| Early death | 187 (34) | 9 (10) | <.001 |
| Renal response | |||
| 6 mo | n = 476 | n = 85 | |
| Response | 130 (27) | 22 (26) | Eval.: .004 |
| Stable | 61 (13) | 29 (34) | ITT: <.001 |
| Progression | 98 (21) | 25 (29) | |
| Early death | 187 (39) | 9 (11) | |
| 12 mo | n = 501 | n = 81 | |
| Response | 122 (24) | 25 (31) | Eval.: .123 |
| Stable | 34 (7) | 15 (19) | ITT: <.001 |
| Progression | 105 (21) | 29 (36) | |
| Early death | 240 (48) | 12 (15) |
| . | dFLC ≥50 mg/L . | dFLC <50 mg/L . | P* . |
|---|---|---|---|
| Hematologic response | |||
| 3 mo | n = 565 | n = 85 | |
| aCR | 34 (6) | 20 (24) | <.001 |
| Low-dFLC PR | n.a. | 18 (21) | n.a. |
| VGPR | 137 (24 | n.a. | n.a. |
| PR | 132 (23) | n.a. | n.a. |
| No response | 144 (26) | 41 (48) | .001 |
| Early death | 118 (21) | 6 (7) | .002 |
| 6 mo | n = 554 | n = 88 | |
| aCR | 48 (9) | 34 (39) | <.001 |
| Low-dFLC PR | n.a. | 14 (16) | n.a. |
| VGPR | 130 (23) | n.a. | n.a. |
| PR | 112 (20) | n.a. | n.a. |
| No response | 77 (14) | 31 (35) | .001 |
| Early death | 187 (34) | 9 (10) | <.001 |
| Renal response | |||
| 6 mo | n = 476 | n = 85 | |
| Response | 130 (27) | 22 (26) | Eval.: .004 |
| Stable | 61 (13) | 29 (34) | ITT: <.001 |
| Progression | 98 (21) | 25 (29) | |
| Early death | 187 (39) | 9 (11) | |
| 12 mo | n = 501 | n = 81 | |
| Response | 122 (24) | 25 (31) | Eval.: .123 |
| Stable | 34 (7) | 15 (19) | ITT: <.001 |
| Progression | 105 (21) | 29 (36) | |
| Early death | 240 (48) | 12 (15) |
Data are shown as counts (percentages of n). See “Methods” for definition of aCR and PR. Organ response criteria were applied according to Gertz et al and Palladini et al.8,19 Dialysis was assigned as renal progression.
Early death, death before envisaged follow-up; Eval., P value with respect to evaluable patients; ITT, intention-to-treat P value includes patients who experienced early death; Low-dFLC PR, drop of dFLC <10 mg/L if the initial dFLC was 0.20 mg/L (only in cases without aCR and for patients with a dFLC <50 mg/L); n, number of patients evaluable for hematologic or organ response, including early death; na, not applicable; No response, less than PR, progress, or start of second-line chemotherapy; VGPR, very good PR (only patients with a dFLC ≥50 mg/L).
P values in italics indicate statistical significance.