Grade 3/4 adverse events during induction treatment of patients distributed by VMPT-VT and VMP arms and by renal cohorts
| Adverse events, n (%) . | VMPT-VT arm, estimated glomerular filtration rate . | VMP arm, estimated glomerular filtration rate . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total (n = 232) . | ≤ 30 (n = 14) . | 31-50 (n = 56) . | ≤ 50 (n = 70) . | > 50 (n = 162) . | Total (n = 241) . | ≤ 30 (n = 19) . | 31-50 (n = 60) . | ≤ 50 (n = 79) . | > 50 (n = 162) . | |
| Hematologic events | 109 (47) | 9 (64.3) | 33 (58.9) | 42 (60) | 67 (41.4) | 97 (40.2) | 11 (57.9) | 31 (51.7) | 42 (53.2) | 55 (34) |
| Neutropenia | 87 (37.5) | 8 (57.1)* | 25 (44.6) | 33 (47.1) | 54 (33.3) | 65 (27) | 4 (21.1) | 21 (35) | 25 (31.6) | 40 (24.7) |
| Thrombocytopenia | 50 (21.6) | 6 (44.9) | 17 (34.4) | 23 (32.9) | 27 (16.7) | 47 (19.5) | 6 (31.6) | 19 (31.7) | 25 (31.6) | 22 (13.6) |
| Anemia | 25 (10.8) | 4 (28.6) | 12 (21.4) | 16 (22.9) | 9 (5.6) | 24 (10) | 6 (31.6) | 8 (13.3) | 14 (17.7) | 10 (6.2) |
| Cardiologic events | 25 (10.8) | 3 (21.4) | 9 (16.1) | 12 (17.1) | 13 (8) | 11 (4.6) | 1 (5.3) | 4 (6.7) | 5 (6.3) | 6 (3.7) |
| Infections | 31 (13.4) | 1 (7.1) | 10 (17.9) | 11 (17.5) | 20 (12.3) | 22 (9.1) | 4 (21) | 6 (10) | 10 (12.7) | 12 (7.4) |
| Gastrointestinal events | 16 (6.9) | 2 (14.3) | 5 (8.9) | 7 (10) | 9 (5.1) | 20 (8.3) | 2 (10.5) | 3 (5) | 5 (6.3) | 15 (9.3) |
| Vascular events | 13 (5.6) | 2 (14.3) | 5 (8.9) | 7 (10) | 6 (3.7) | 5 (2.1) | 0 (0) | 1 (1.7) | 1 (1.3) | 4 (2.5) |
| Systemic events | 16 (6.9) | 2 (14.3) | 6 (10.7) | 8 (11.4) | 8 (4.9) | 8 (3.3) | 2 (10.5) | 3 (5) | 5 (6.3) | 3 (1.9) |
| Dermatologic events | 9 (3.9) | 1 (7.1) | 4 (7.1) | 5 (7.1) | 4 (2.5) | 6 (2.5) | 0 (0) | 1 (1.7) | 1 (1.3) | 5 (3.1) |
| Sensory neuropathy and/or neuralgia | 32 (13.8) | 3 (21.4) | 7 (12.5) | 10 (14.3) | 22 (13.6) | 28 (11.6) | 2 (10.5) | 4 (6.7) | 6 (7.6) | 22 (13.6) |
| Discontinuation attributable to adverse events | 51 (22) | 4 (28.6) | 14 (25) | 18 (25.7) | 33 (20.4) | 34 (14.1) | 4 (21.1) | 6 (10)† | 10 (12.7) | 24 (14.8) |
| Adverse events, n (%) . | VMPT-VT arm, estimated glomerular filtration rate . | VMP arm, estimated glomerular filtration rate . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total (n = 232) . | ≤ 30 (n = 14) . | 31-50 (n = 56) . | ≤ 50 (n = 70) . | > 50 (n = 162) . | Total (n = 241) . | ≤ 30 (n = 19) . | 31-50 (n = 60) . | ≤ 50 (n = 79) . | > 50 (n = 162) . | |
| Hematologic events | 109 (47) | 9 (64.3) | 33 (58.9) | 42 (60) | 67 (41.4) | 97 (40.2) | 11 (57.9) | 31 (51.7) | 42 (53.2) | 55 (34) |
| Neutropenia | 87 (37.5) | 8 (57.1)* | 25 (44.6) | 33 (47.1) | 54 (33.3) | 65 (27) | 4 (21.1) | 21 (35) | 25 (31.6) | 40 (24.7) |
| Thrombocytopenia | 50 (21.6) | 6 (44.9) | 17 (34.4) | 23 (32.9) | 27 (16.7) | 47 (19.5) | 6 (31.6) | 19 (31.7) | 25 (31.6) | 22 (13.6) |
| Anemia | 25 (10.8) | 4 (28.6) | 12 (21.4) | 16 (22.9) | 9 (5.6) | 24 (10) | 6 (31.6) | 8 (13.3) | 14 (17.7) | 10 (6.2) |
| Cardiologic events | 25 (10.8) | 3 (21.4) | 9 (16.1) | 12 (17.1) | 13 (8) | 11 (4.6) | 1 (5.3) | 4 (6.7) | 5 (6.3) | 6 (3.7) |
| Infections | 31 (13.4) | 1 (7.1) | 10 (17.9) | 11 (17.5) | 20 (12.3) | 22 (9.1) | 4 (21) | 6 (10) | 10 (12.7) | 12 (7.4) |
| Gastrointestinal events | 16 (6.9) | 2 (14.3) | 5 (8.9) | 7 (10) | 9 (5.1) | 20 (8.3) | 2 (10.5) | 3 (5) | 5 (6.3) | 15 (9.3) |
| Vascular events | 13 (5.6) | 2 (14.3) | 5 (8.9) | 7 (10) | 6 (3.7) | 5 (2.1) | 0 (0) | 1 (1.7) | 1 (1.3) | 4 (2.5) |
| Systemic events | 16 (6.9) | 2 (14.3) | 6 (10.7) | 8 (11.4) | 8 (4.9) | 8 (3.3) | 2 (10.5) | 3 (5) | 5 (6.3) | 3 (1.9) |
| Dermatologic events | 9 (3.9) | 1 (7.1) | 4 (7.1) | 5 (7.1) | 4 (2.5) | 6 (2.5) | 0 (0) | 1 (1.7) | 1 (1.3) | 5 (3.1) |
| Sensory neuropathy and/or neuralgia | 32 (13.8) | 3 (21.4) | 7 (12.5) | 10 (14.3) | 22 (13.6) | 28 (11.6) | 2 (10.5) | 4 (6.7) | 6 (7.6) | 22 (13.6) |
| Discontinuation attributable to adverse events | 51 (22) | 4 (28.6) | 14 (25) | 18 (25.7) | 33 (20.4) | 34 (14.1) | 4 (21.1) | 6 (10)† | 10 (12.7) | 24 (14.8) |
Comparison for all variables reported in the table the following subgroups: VMPT-VT patients with eGFR ≤ 30 vs VMP patients with eGFR ≤ 30; VMPT-VT patients with eGFR ≤ 30 vs VMPT-VT patients with eGFR 31-50, VMPT-VT patients with eGFR 31-50 vs VMP patients with eGFR 31-50, VMP patients with eGFR ≤ 30 vs VMP patients with eGFR 31-50 only differences resulted statistically significant have been reported in the table.
VMP indicates bortezomib-melphalan-prednisone; and VMPT-VT, bortezomib-melphalan-prednisone-thalidomide following by bortezomib-thalidomide maintenance.
P = .033 for the comparison with VMP patients with eGFR < 30.
P = .033 for the comparison with VMPT-VT patients with eGFR 31-50 and P = .21 for the comparison with VMP patients with eGFR ≤ 30.