Patient demographics, baseline characteristics, and disease history
| . | N = 55 . |
|---|---|
| Female/male, n (%) | 26/29 (47.3/52.7) |
| Median age, y (range) | 61 (41-88) |
| Age ≥65 y, n (%) | 21 (38.2) |
| ECOG performance status, n (%) | |
| 0 | 26 (47.3) |
| 1 | 25 (45.5) |
| 2 | 4 (7.3) |
| Baseline serum albumin (g/L), median (range) | 36.9 (30.6-48.9) |
| Baseline serum M protein (g/L), median (range) | 26.0 (0-66.0) |
| Baseline urine M protein (mg/24 h), median (range) | 283 (0-9628) |
| ISS staging, n (%) | |
| Stage 1 | 18 (32.7) |
| Stage 2 | 23 (41.8) |
| Stage 3 | 13 (23.6) |
| Missing* | 1 (1.8) |
| Immunoglobulin subtype, n (%) | |
| IgG | 35 (63.6) |
| IgA | 12 (21.8) |
| IgM | 1 (1.8) |
| Indeterminate | 7 (12.7) |
| Light-chain subtype, n (%) | |
| κ | 37 (67.3) |
| Λ | 16 (29.1) |
| Indeterminate | 2 (3.6) |
| FISH, n (%) | |
| Normal | 2 (3.6) |
| Any abnormality† | 35 (63.6) |
| del(17p), t(4;14), or t(14;16) | 14 (25.5) |
| del(13q) | 5 (9.1) |
| t(11;14) | 14 (25.5) |
| 3+ | 1 (1.8) |
| Median time since diagnosis, months (range) | 54.8 (7.5-263.6) |
| Prior regimens, median (range) | 4 (2-11) |
| Prior therapy, n (%) | |
| BTZ | 55 (100.0) |
| DEX | 55 (100.0) |
| Lenalidomide | 54 (98.2) |
| Thalidomide | 38 (69.1) |
| Prior autologous stem cell transplant, n (%) | 31 (56.4) |
| Median cumulative duration of prior BTZ‡, months (range) | 8.7 (1.6-42.6) |
| Prior BTZ regimens, median (range) | 2 (1-6) |
| Progressed while on last BTZ regimen, n (%) | 40 (72.7) |
| Progressed ≤60 d after last BTZ regimen, n (%) | 15 (27.3) |
| BTZ in most recent prior regimen, n (%) | 27 (49.1) |
| DEX in most recent prior regimen, n (%) | 37 (67.3) |
| DEX in last BTZ-containing regimen, n (%) | 45 (81.8) |
| Best response at last treatment, n (%) | |
| Complete response | 1 (1.8) |
| Partial response | 11 (20.0) |
| Minimal response | 10 (18.2) |
| Stable disease | 8 (14.5) |
| Progressive disease | 17 (30.9) |
| None | 5 (9.1) |
| Unknown | 3 (5.5) |
| . | N = 55 . |
|---|---|
| Female/male, n (%) | 26/29 (47.3/52.7) |
| Median age, y (range) | 61 (41-88) |
| Age ≥65 y, n (%) | 21 (38.2) |
| ECOG performance status, n (%) | |
| 0 | 26 (47.3) |
| 1 | 25 (45.5) |
| 2 | 4 (7.3) |
| Baseline serum albumin (g/L), median (range) | 36.9 (30.6-48.9) |
| Baseline serum M protein (g/L), median (range) | 26.0 (0-66.0) |
| Baseline urine M protein (mg/24 h), median (range) | 283 (0-9628) |
| ISS staging, n (%) | |
| Stage 1 | 18 (32.7) |
| Stage 2 | 23 (41.8) |
| Stage 3 | 13 (23.6) |
| Missing* | 1 (1.8) |
| Immunoglobulin subtype, n (%) | |
| IgG | 35 (63.6) |
| IgA | 12 (21.8) |
| IgM | 1 (1.8) |
| Indeterminate | 7 (12.7) |
| Light-chain subtype, n (%) | |
| κ | 37 (67.3) |
| Λ | 16 (29.1) |
| Indeterminate | 2 (3.6) |
| FISH, n (%) | |
| Normal | 2 (3.6) |
| Any abnormality† | 35 (63.6) |
| del(17p), t(4;14), or t(14;16) | 14 (25.5) |
| del(13q) | 5 (9.1) |
| t(11;14) | 14 (25.5) |
| 3+ | 1 (1.8) |
| Median time since diagnosis, months (range) | 54.8 (7.5-263.6) |
| Prior regimens, median (range) | 4 (2-11) |
| Prior therapy, n (%) | |
| BTZ | 55 (100.0) |
| DEX | 55 (100.0) |
| Lenalidomide | 54 (98.2) |
| Thalidomide | 38 (69.1) |
| Prior autologous stem cell transplant, n (%) | 31 (56.4) |
| Median cumulative duration of prior BTZ‡, months (range) | 8.7 (1.6-42.6) |
| Prior BTZ regimens, median (range) | 2 (1-6) |
| Progressed while on last BTZ regimen, n (%) | 40 (72.7) |
| Progressed ≤60 d after last BTZ regimen, n (%) | 15 (27.3) |
| BTZ in most recent prior regimen, n (%) | 27 (49.1) |
| DEX in most recent prior regimen, n (%) | 37 (67.3) |
| DEX in last BTZ-containing regimen, n (%) | 45 (81.8) |
| Best response at last treatment, n (%) | |
| Complete response | 1 (1.8) |
| Partial response | 11 (20.0) |
| Minimal response | 10 (18.2) |
| Stable disease | 8 (14.5) |
| Progressive disease | 17 (30.9) |
| None | 5 (9.1) |
| Unknown | 3 (5.5) |
BTZ, bortezomib; del, deletion; DEX, dexamethasone; ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization; Ig, immunoglobulin; ISS, International Staging System; t, translocation.
One patient did not have baseline β2 microglobulin measurement.
Not all subcategories of abnormalities are presented, and patients could present with more than 1 abnormality.
One patient had missing data.