Abstract
Introduction: We previously reported that plerixafor + G-CSF was as safe as and more effective than placebo + G-CSF in mobilizing hematopoietic stem cell for autologous transplant in patients with multiple myeloma (MM) through 100 days follow-up (DiPersio ASH 2007). We report herein the 12 months data.
Methods: This is a phase 3, multi-center, randomized (1:1), double-blind, placebocontrolled study. Multiple myeloma patients requiring an autologous hematopoietic stem cell transplant, in first or second complete or partial remission were eligible. Patients received G-CSF (10μg/kg/day) subcutaneously for up to 8 days. Beginning on evening of Day 4 and continuing daily for up to 4 days, patients received either plerixafor (240μg/kg) or placebo subcutaneously. Starting on Day 5, patients began daily apheresis for up to 4 days or until ≥ 6 x 106 CD34+cells/kg were collected. We report herein the 12 months graft durability and hematology data.
Results: As reported previously, the primary endpoint of collecting ≥ 6 x 106 CD34+ cells/kg in ≤ 2 days of apheresis was met in 106/148 (71.6%) patients in the plerixafor group and 53/154 (34.4%) patients in the placebo group, p<0.001. 142 (96%) patients in plerixafor group and 136 (88%) patients in placebo group underwent transplantation. Median time to PMN and PLT engraftment was similar in both groups. Through 12 months follow-up, there were no differences in graft durability and hematology profiles between groups (Table 1). Over the 12 months, 6/142 (4.2%) patients in the plerixafor group and 5/136 (3.7%) patients in the placebo group died. Of the patients who died, 2 patients in the plerixafor group and 2 patients in the placebo grouped died due to disease progression.
| . | Plerixafor + G-CSF . | Placebo + G-CSF . |
|---|---|---|
| Hematology data presented as mean ± SD and n=number of patients with available data P values were NS for all variables at all time points between groups | ||
| aAll patients who underwent transplantation | ||
| bAll patients who underwent transplantation and had laboratory data at the study visit | ||
| Graft durability (n, %) | ||
| 100 daysa | 140/142 (98.6%) | 133/136 (97.8%) |
| 6 monthsb | 133/135 (98.5%) | 125/127 (98.4%) |
| 12 monthsb | 127/128 (99.2%) | 119/120 (99.2%) |
| Platelet (x 109/L) | ||
| 100 days | 226 ± 80 (n=90) | 210 ± 88 (n=87) |
| 6 months | 218 ± 67 (n=95) | 209 ± 89 (n=93) |
| 12 months | 204 ± 69 (n=53) | 205 ± 80 (n=54) |
| Neutrophils (x 109/L) | ||
| 100 days | 3.3 ± 2.3 (n=88) | 3.0 ± 1.7 (n=80) |
| 6 months | 3.4 ± 1.6 (n=90) | 3.5 ± 1.8 (n=88) |
| 12 months | 3.1 ± 1.1 (n=52) | 3.6 ± 2.1 (n=52) |
| Hemoglobin (mg/dL) | ||
| 100 days | 12.5 ± 1.5 (n=89) | 12.6 ± 1.3 (n=86) |
| 6 months | 12.7 ± 1.4 (n=94) | 12.7 ± 1.6 (n=92) |
| 12 months | 12.9 ± 1.8 (n=53) | 13.1 ± 1.5 (n=54) |
| . | Plerixafor + G-CSF . | Placebo + G-CSF . |
|---|---|---|
| Hematology data presented as mean ± SD and n=number of patients with available data P values were NS for all variables at all time points between groups | ||
| aAll patients who underwent transplantation | ||
| bAll patients who underwent transplantation and had laboratory data at the study visit | ||
| Graft durability (n, %) | ||
| 100 daysa | 140/142 (98.6%) | 133/136 (97.8%) |
| 6 monthsb | 133/135 (98.5%) | 125/127 (98.4%) |
| 12 monthsb | 127/128 (99.2%) | 119/120 (99.2%) |
| Platelet (x 109/L) | ||
| 100 days | 226 ± 80 (n=90) | 210 ± 88 (n=87) |
| 6 months | 218 ± 67 (n=95) | 209 ± 89 (n=93) |
| 12 months | 204 ± 69 (n=53) | 205 ± 80 (n=54) |
| Neutrophils (x 109/L) | ||
| 100 days | 3.3 ± 2.3 (n=88) | 3.0 ± 1.7 (n=80) |
| 6 months | 3.4 ± 1.6 (n=90) | 3.5 ± 1.8 (n=88) |
| 12 months | 3.1 ± 1.1 (n=52) | 3.6 ± 2.1 (n=52) |
| Hemoglobin (mg/dL) | ||
| 100 days | 12.5 ± 1.5 (n=89) | 12.6 ± 1.3 (n=86) |
| 6 months | 12.7 ± 1.4 (n=94) | 12.7 ± 1.6 (n=92) |
| 12 months | 12.9 ± 1.8 (n=53) | 13.1 ± 1.5 (n=54) |
Conclusions: The addition of plerixafor to G-CSF resulted in higher CD34+ cell collection in fewer days of apheresis than G-CSF alone. Importantly, this 12 months report showed that transplants with cells collected with plerixafor resulted in graft durability rates that were similar to cells collected with G-CSF alone.
Disclosures: DiPersio:Genzyme: Research Funding. Stadtmauer:Genzyme: Honoraria. Micallef:Genzyme: Honoraria, Research Funding. Stiff:Genzyme: Honoraria, Research Funding. Bridger:Genzyme: Consultancy. Calandra:Genzyme: Consultancy.
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