Patient demographics and baseline characteristics at entry into IFM 2009-02, unless specified (N = 84)
| Characteristic . | 21/28 (N = 43) . | 28/28 (N = 41) . |
|---|---|---|
| Median time from diagnosis to randomization, years (range) | 5.1 (0.9- 8.7) | 6.5 (0.8-23.1) |
| ≤3 years, n (%) | 13 (30) | 4 (10) |
| Median age, years (range) | 60 (45-81) | 60 (42-83) |
| Age ≥65 years, n (%) | 11 (26) | 15 (37) |
| ISS stage, %* | ||
| II/III | 32 / 24 | 42 / 17 |
| Myeloma type, n (%) | ||
| Intact Ig | 36 (84) | 34 (83) |
| Light chain | 4 (9) | 5 (12) |
| Freelite® measurable only† | 3 (7) | 2 (5) |
| Lytic bone lesions, n (%) | 37 (86) | 37 (90) |
| Yes | 31 (86) | 32 (86.5) |
| Number of lytic lesions: [3-6] | 9 (25) | 8 (22) |
| Number of lytic lesions: > 6 | 11 (31) | 17 (46) |
| Osseous Fracture | 10 (29) | 11 (32) |
| Medullary compression | 0 | 3 (9) |
| Plasmacytoma | 9 (21) | 5 (12) |
| Median β2-microglobulin, mg/L (range) | 3.9 (1.0-13.2) | 3.7 (1.6-12.0) |
| (3.5, 5.5) mg/L, n (%) | 19 (44) | 11 (27.5) |
| >5.5 mg/L, n (%) | 10 (23) | 11 (27.5) |
| Median albumin, g/L (range) | 37.1 (24.6-49.5) | 38.2 (28.1-46.6) |
| Median serum creatinine, (µmol/l) (range) | 80.0 (44.0-193.0) | 87.0 (42.0-196.0) |
| >115 µmol/L, n (%) | 6 (14) | 4 (10) |
| Median hemoglobin, g/dL (range) | 10.5 (7.2-14.1) | 10.5 (6.4-14.1) |
| <10 g/dL, n (%) | 18 (42) | 15 (37.5) |
| Median neutrophils, ×109/L (range) | 2.6 (0.04-10.4) | 2.3 (0.9-8.3) |
| Median platelets, x109/L (range) | 161 (51-366) | 147 (33-269) |
| <100 G/L, n (%) | 8 (19) | 10 (25) |
| Median number of lines | 5 | 5 |
| (min-max) | (1-13) | (2-10) |
| Characteristic . | 21/28 (N = 43) . | 28/28 (N = 41) . |
|---|---|---|
| Median time from diagnosis to randomization, years (range) | 5.1 (0.9- 8.7) | 6.5 (0.8-23.1) |
| ≤3 years, n (%) | 13 (30) | 4 (10) |
| Median age, years (range) | 60 (45-81) | 60 (42-83) |
| Age ≥65 years, n (%) | 11 (26) | 15 (37) |
| ISS stage, %* | ||
| II/III | 32 / 24 | 42 / 17 |
| Myeloma type, n (%) | ||
| Intact Ig | 36 (84) | 34 (83) |
| Light chain | 4 (9) | 5 (12) |
| Freelite® measurable only† | 3 (7) | 2 (5) |
| Lytic bone lesions, n (%) | 37 (86) | 37 (90) |
| Yes | 31 (86) | 32 (86.5) |
| Number of lytic lesions: [3-6] | 9 (25) | 8 (22) |
| Number of lytic lesions: > 6 | 11 (31) | 17 (46) |
| Osseous Fracture | 10 (29) | 11 (32) |
| Medullary compression | 0 | 3 (9) |
| Plasmacytoma | 9 (21) | 5 (12) |
| Median β2-microglobulin, mg/L (range) | 3.9 (1.0-13.2) | 3.7 (1.6-12.0) |
| (3.5, 5.5) mg/L, n (%) | 19 (44) | 11 (27.5) |
| >5.5 mg/L, n (%) | 10 (23) | 11 (27.5) |
| Median albumin, g/L (range) | 37.1 (24.6-49.5) | 38.2 (28.1-46.6) |
| Median serum creatinine, (µmol/l) (range) | 80.0 (44.0-193.0) | 87.0 (42.0-196.0) |
| >115 µmol/L, n (%) | 6 (14) | 4 (10) |
| Median hemoglobin, g/dL (range) | 10.5 (7.2-14.1) | 10.5 (6.4-14.1) |
| <10 g/dL, n (%) | 18 (42) | 15 (37.5) |
| Median neutrophils, ×109/L (range) | 2.6 (0.04-10.4) | 2.3 (0.9-8.3) |
| Median platelets, x109/L (range) | 161 (51-366) | 147 (33-269) |
| <100 G/L, n (%) | 8 (19) | 10 (25) |
| Median number of lines | 5 | 5 |
| (min-max) | (1-13) | (2-10) |