Table 1.
Baseline patient characteristics (safety set)
| FCM (n = 8) | Controlsd (n = 11) | ||
|---|---|---|---|
| Male, n (%) | 5 (62.5) | 7 (63.6) | |
| Age (years, median [range]) | 69.5 [41–79] | 71.0 [26–88] | |
| Weight (kg, median [range]) | 67.8 [59.0–103.7] | 66.4 [49.0–78.0] | |
| Baseline Hb and iron status | Hb (g/dL, median [range]) | 9.5 [9.0–10.5] | 9.8 [8.4–10.6] |
| Ferritin (ng/mL, median [range])a | 216 [65–800] | 322 [8–707] | |
| TSAT (%, median [range])a | 16 [3–35] | 18 [0–31] | |
| Previous anti-anemic therapyb, n (%) | Transfusion | 3 (37.5) | 1 (9.1) |
| ESA | 0 | 1 (9.1) | |
| iron | 0 | 1 (9.1) | |
| Tumor type, n (%) | Multiple myeloma | 6 (75.0) | 5 (45.5) |
| Chronic lymphocytic leukemia | 1 (12.5) | 1 (9.1) | |
| Non-Hodgkin’s lymphoma | 1 (12.5) | 5 (45.5) | |
| Cancer therapy Mono- or combined (n)c | Antineoplastic agents | 8 | 10 |
| Bendamustine | 0 | 1 | |
| Bortezomib | 3 | 3 | |
| Chlorambucil | 1 | 2 | |
| Cyclophosphamide | 3 | 2 | |
| Doxorubicin | 0 | 1 | |
| Fludarabine | 0 | 1 | |
| Melphalan | 2 | 5 | |
| Vincristine | 1 | 1 | |
| Thalidomide | 1 | 1 | |
| Corticosteroids for systemic use | 7 | 6 | |
| Dexamethasone | 4 | 3 | |
| Prednisone | 3 | 4 | |
aPatients with baseline TSAT >20 % and ferritin ≤30 (women) or ≤40 ng/mL (men) were excluded from the per-protocol population (3 FCM, 2 Control)
b>4 weeks prior to baseline
cAs per protocol, patients had to be receiving cancer treatment
dSymptomatic management according to local institutional practice