Table 1.
Characteristics of patients at screening.
| Characteristic | All patients |
|---|---|
| N = 437 | |
| Age (years) | |
| Median (range) | 64 (34–85) |
| ≤65 | 229 (52%) |
| 65–74 | 160 (37%) |
| ≥75 | 48 (11%) |
| Sex | |
| Male | 236 (54%) |
| Female | 201 (46%) |
| Race | |
| White | 341 (78%) |
| Black or African American | 55 (13%) |
| Asian | 10 (2%) |
| Other/unknown | 31 (7%) |
| ECOG performance status at screening | |
| 0 | 108 (25%) |
| 1 | 280 (64%) |
| 2 | 38 (9%) |
| 3 | 1 (<1%) |
| Unknown | 10 (2%) |
| ISS disease stage at initial diagnosis | |
| I | 95 (22%) |
| II | 87 (20%) |
| III | 127 (29%) |
| IV | 2 (<1%) |
| Unknown/missing | 126 (29%) |
| Median time since initial diagnosis of multiple myeloma | |
| Years (range) | 5 (<1–35) |
| Number of prior therapeutic regimens | 6 (0–18) |
| 0 | 2 (<1%) |
| 1 | 42 (10%) |
| 2 | 27 (6%) |
| 3 | 26 (6%) |
| 4 | 37 (8%) |
| 5 | 56 (13%) |
| ≥6 | 247 (57%) |
| Selinexor starting dose and treatment regimen | |
| Selinexor (80 mg) + dexamethasone (20 mg)a | 214 (49%) |
| KCP-330-001 | 12 (6%)b |
| KCP-330-012 Part A | 79 (37%)b |
| KCP-330-012 Part B | 123 (57%)b |
| Selinexor (< or >80 mg) ± dexamethasone (20 mg) | 70 (16%) |
| Selinexor/bortezomib/dexamethasonec | 78 (18%) |
| Selinexor/lenalidomide/dexamethasoned | 24 (5%) |
| Selinexor/pomalidomide/dexamethasonee | 33 (8%) |
| Selinexor/daratumumab/dexamethasonef | 18 (4%) |
| Abnormalities in baseline clinical and laboratory tests | |
| Median (range) | 13 (1–62) |
| Nausea at screening | |
| None | 386 (88%) |
| Grade 1 | 31 (7%) |
| Grade 2 | 4 (<1%) |
| Ongoing with unknown grade | 16 (4%) |
| Diarrhea at screening | |
| None | 378 (86%) |
| Grade 1 | 36 (8%) |
| Grade 2 | 6 (1%) |
| Ongoing with unknown grade | 17 (4%) |
| Fatigue or asthenia at screening | |
| None | 273 (62%) |
| Grade 1 | 95 (22%) |
| Grade 2 | 18 (4%) |
| Ongoing with unknown grade | 51 (12%) |
| Decreased appetite at screening | |
| None | 411 (94%) |
| Grade 1 | 16 (4%) |
| Grade 2 | 4 (<1%) |
| Ongoing with unknown grade | 6 (1%) |
| Platelet count at screening | |
| Above lower limit of normal | 249 (57%) |
| <150,000–75,000/mm3 | 117 (27%) |
| <75,000–50,000/mm3 | 39 (9%) |
| <50,000–25,000/mm3 | 24 (6%) |
| <25,000/mm3 | 6 (1%) |
| Neutrophil count at screening | |
| Above lower limit of normal | 315 (72%) |
| <2000–1500/mm3 | 64 (15%) |
| <1500–1000/mm3 | 40 (9%) |
| <1000–500/mm3 | 10 (2%) |
| <500/mm3 | 2 (<1%) |
| Hemoglobin at screening | |
| Above lower limit of normal | 46 (11%) |
| <Lower limit of normal–10.0 g/dL | 182 (42%) |
| <10.0–8.0 g/dL | 174 (40%) |
| <8.0 g/dL | 34 (8%) |
| Plasma sodium at screening | |
| Above lower limit of normal | 411 (94%) |
| Grade 1 | 18 (4%) |
| Grade 2 | 1 (<1%) |
| Grade 3 | 4 (<1%) |
| Ongoing with unknown grade | 3 (<1%) |
| Concomitant medications at screening | |
| Median (range) | 7 (0–21) |
ECOG Eastern Cooperative Oncology Group, ISS International Staging System.
aPercentage of N = 214.
bSelinexor (80 mg twice-weekly)/dexamethasone (20 mg twice-weekly).
cSelinexor (60 or 80 mg twice-weekly, or 80 or 100 mg once-weekly)/bortezomib (1.3 mg/m2 once-weekly or twice-weekly/dexamethasone (20 mg twice-weekly or 40 mg once-weekly).
dSelinexor (60 or 80 mg twice-weekly, or 80 or 100 mg once-weekly)/lenalidomide (25 mg once-daily)/dexamethasone (20 mg twice-weekly or 40 mg once-weekly).
eSelinexor (60 or 80 mg twice-weekly, or 60, 80 or 100 mg once-weekly)/pomalidomide (2, 3, or 4 mg once-daily)/dexamethasone (20 mg twice-weekly or 40 mg once-weekly).
fSelinexor (60 mg twice-weekly or 100 mg once-weekly/daratumumab (intravenous, 16 mg/kg once-weekly)/dexamethasone (20 mg twice-weekly or 40 mg once-weekly).