Patient demographic and clinical characteristics (n = 22+, phase 1a = 8, phase 1b = 19)
| . | Phase 1a . | Phase 1b . | ||
|---|---|---|---|---|
| Characteristics . | Median . | n (%) . | Median . | n (%) . |
| Age (y) | 69.5 (range: 34-77) | 62.0 (range: 35-79) | ||
| Gender Male Female | Male: 6 (75.0) Female: 2 (25.0) | 13 (68.4) 6 (31.6) | ||
| Race White Black Other Unknown | 5 (62.5) 0 (0) 1 (12.5) 2 (25) | 15 (78.9) 1 (5.3) 2 (10.5) 1 (5.3) | ||
| Light chain type κ γ | 2 (25.0) 6 (75.0) | 10 (52.6) 9 (47.4) | ||
| Organ involvement* Cardiac Renal Skin/soft tissue GI Nervous system Liver MSK Other | 5 (62.5) 3 (37.5) 4 (50) 3 (37.5) 0 (0) 1 (12.5) 1 (12.5) 0 (0) | 11 (57.9) 10 (52.6) 8 (42.1) 5 (26.3) 3 (15.8) 2 (10.5) 2 (10.5) 1 (5.3) | ||
| Hematologic disease status at the time of study enrollment CR VGPR PR | 3 (37.5) 2 (25) 3 (37.5) | 7 (36.8) 8 (42.1) 3 (15.8) 1 (5.3) | ||
| Previous plasma cell-directed therapy 1 regimen 2 regimens 3 regimens >3 regimens | 2 (range: 1-9) | 1 (12.5) 4 (50) 0 (0) 3 (37.5) | 2 (range: 1-6) | 6 (31.6) 4 (21.1) 2 (10.5) 7 (36.8) |
| Baseline NT-proBNP (ng/L)† | 3298.0 (range: 903–13 131) | 1592.6 (range: 850.1-3964) | ||
| Baseline 24 h urine protein (mg/24 hr)‡ | 3560.5 (range: 1200-10 260) | 5236.0 (range: 1078-7260) | ||
| Time since last exposure to chemotherapy (mo) | 2.6 (range: 1-12.0) | 7.4 (range: 0-15.5) | ||
| . | Phase 1a . | Phase 1b . | ||
|---|---|---|---|---|
| Characteristics . | Median . | n (%) . | Median . | n (%) . |
| Age (y) | 69.5 (range: 34-77) | 62.0 (range: 35-79) | ||
| Gender Male Female | Male: 6 (75.0) Female: 2 (25.0) | 13 (68.4) 6 (31.6) | ||
| Race White Black Other Unknown | 5 (62.5) 0 (0) 1 (12.5) 2 (25) | 15 (78.9) 1 (5.3) 2 (10.5) 1 (5.3) | ||
| Light chain type κ γ | 2 (25.0) 6 (75.0) | 10 (52.6) 9 (47.4) | ||
| Organ involvement* Cardiac Renal Skin/soft tissue GI Nervous system Liver MSK Other | 5 (62.5) 3 (37.5) 4 (50) 3 (37.5) 0 (0) 1 (12.5) 1 (12.5) 0 (0) | 11 (57.9) 10 (52.6) 8 (42.1) 5 (26.3) 3 (15.8) 2 (10.5) 2 (10.5) 1 (5.3) | ||
| Hematologic disease status at the time of study enrollment CR VGPR PR | 3 (37.5) 2 (25) 3 (37.5) | 7 (36.8) 8 (42.1) 3 (15.8) 1 (5.3) | ||
| Previous plasma cell-directed therapy 1 regimen 2 regimens 3 regimens >3 regimens | 2 (range: 1-9) | 1 (12.5) 4 (50) 0 (0) 3 (37.5) | 2 (range: 1-6) | 6 (31.6) 4 (21.1) 2 (10.5) 7 (36.8) |
| Baseline NT-proBNP (ng/L)† | 3298.0 (range: 903–13 131) | 1592.6 (range: 850.1-3964) | ||
| Baseline 24 h urine protein (mg/24 hr)‡ | 3560.5 (range: 1200-10 260) | 5236.0 (range: 1078-7260) | ||
| Time since last exposure to chemotherapy (mo) | 2.6 (range: 1-12.0) | 7.4 (range: 0-15.5) | ||
Five patients participated in both phase 1a and 1b of this study. Their data are entered separately in this table.
Values exceeded 100% because some patients had more than 1 organ involved.
Baseline NT-proBNP in patients with cardiac involvement who were evaluable for response ie, patients with baseline NT-proBNP ≥650 pg/mL (n = 4 in phase 1a and n = 8 in phase 1b).
Baseline 24-h urine protein in patients evaluable for renal response (n = 5 in phase 1a and n = 11 in phase 1b).