Table 1.
Patient Demographic and Baseline Characteristics
| Isa-VCd (N = 17)a |
|
|---|---|
| Age | |
| Median (range), y | 71.0 (68–80) |
| Age group, n (%) | |
| <65 y | 0 |
| 65–74 y | 13 (76.5) |
| ≥75 y | 4 (23.5) |
| Male, n (%) | 9 (52.9) |
| ECOG PS, n (%) | |
| 0 | 9 (52.9) |
| 1 | 6 (35.3) |
| 2 | 2 (11.8) |
| ISS at initial diagnosis, n (%) | |
| Stage I | 5 (29.4) |
| Stage II | 6 (35.3) |
| Stage III | 6 (35.3) |
| Patients with high-risk cytogenetics, n (%)b,c | 1 (5.9)d |
| Patients 1q21+, n (%)e | 1 (5.9) |
| Median bone marrow plasma cells, % (range) | 30.0 (10.0–85.0) |
| Bone marrow plasma cells (%), by category | |
| 5–<20 | 4 (23.5) |
| 20–<50 | 10 (58.8) |
| ≥50 | 3 (17.6) |
| Plasmacytoma, n (%) | 1 (5.9) |
| Bone lesions, n (%) | 11 (64.7) |
| Creatinine clearance, n (%) | |
| GFR ≥90 mL/min/1.73 m2 (normal) | 2 (11.8) |
| 60 ≤ GFR <90 mL/min/1.73 m2 (mild) | 10 (58.8) |
| 30 ≤ GFR <60 mL/min/1.73 m2 (moderate) | 5 (29.4) |
| 15 ≤ GFR <30 mL/min/1.73 m2 (severe) | 0 |
| GFR <15 mL/min/1.73 m2 (end-stage renal disease) | 0 |
aIsa 10 mg/kg-VCd, n = 13; Isa 20 mg/kg-VCd, n = 4.
bMolecular subtypes were determined by cytogenetic analysis with both local and central fluorescence in situ hybridization assessments.
cTwo patients were not evaluable for 17p deletion or t(4;14) translocation.
dt(4;14).
eSix patients were not evaluable for 1q21+ status.
C = cyclophosphamide; d = dexamethasone; ECOG PS = Eastern Cooperative Oncology Group performance status; GFR = glomerular filtration rate; Isa = isatuximab; ISS = International Staging System; V = bortezomib.