Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.
Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma
Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)
Zubrod (ECOG) performance status < 4
Left ventricular ejection fraction (LVEF) > 40%
Intolerance to auto-HSCT
Prior exposure to other stem cell mobilizing agents
Pregnancy or lactation
Psychiatric disorders precluding participation
Parallel
G-CSF+IL-11
DrugrhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
G-CSF Granulocyte-Colony Stimulating Factor
DrugrhG-CSF 5 μg/kg/day subcutaneously for 6 days
hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment)
Granulocyte Engraftment Time: Defined as the number of days from stem cell infusion (Day 0) to the first of three consecutive days with an Absolute Neutrophil Count (ANC) \> 0.5 × 10\^9/L. Platelet Recovery Time: Defined as the number of days from stem cell infusion (Day 0) to the first day of seven consecutive days with a platelet count (PLT) ≥ 20 × 10\^9/L without transfusion support.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0.
progression-free survival (PFS) and overall survival (OS)
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