This is a multicenter, prospective, single-arm, phase II clinical study evaluating the early prophylactic use of recombinant human thrombopoietin (rhTPO) to prevent thrombocytopenia associated with the EAP regimen for hematopoietic stem cell mobilization. The EAP regimen consists of etoposide, cytarabine, and pegylated granulocyte colony-stimulating factor (pegfilgrastim) and is used for hematopoietic stem cell mobilization before autologous stem cell transplantation in patients with multiple myeloma and B-cell lymphoma.
Severe thrombocytopenia is a common complication during EAP-based stem cell mobilization and may increase the risk of bleeding and the need for platelet transfusions, and may sometimes delay stem cell collection. In this study, patients whose platelet counts decrease to ≤80 × 10⁹/L after EAP chemotherapy will receive rhTPO early as a preventive treatment. The study will evaluate whether early rhTPO administration can reduce the incidence of clinically significant bleeding and the need for platelet transfusion while maintaining adequate hematopoietic stem cell mobilization.
The study will also monitor platelet counts, stem cell collection outcomes, and treatment-related adverse events to evaluate the effectiveness and safety of early rhTPO administration.
Age between 18 and 75 years old.
Confirmed diagnosis of multiple myeloma or B-cell lymphoma, eligible for autologous hematopoietic stem-cell transplantation and planned to receive EAP-based stem-cell mobilization.
Baseline peripheral platelet count ≥ 80 × 10⁹/L.
Adequate cardiac, hepatic and renal function to tolerate EAP-combination chemotherapy.
Previous history of arterial or venous thromboembolism including pulmonary embolism.
Liver cirrhosis or baseline alanine transaminase (ALT) > 2 times upper limit of normal.
Active uncontrolled infection.
Confirmed myelofibrosis.
Single group
rhTPO prophylaxis plus EAP stem-cell mobilization
DrugStandard EAP mobilization chemotherapy (etoposide + cytarabine + pegfilgrastim) plus early prophylactic subcutaneous rhTPO 300 U/kg/day initiated when platelet ≤80 ×10⁹/L. rhTPO stops after stem-cell collection, platelet recovery \>50 ×10⁹/L or investigator's decision. Platelet transfusion follows unified trigger criteria: PLT\<20×10⁹/L or active bleeding.
Platelet transfusion rate during mobilization period
Proportion of participants receiving at least one platelet transfusion in the mobilization phase.
Incidence of grade ≥2 bleeding events during mobilization period
Proportion of participants experiencing CTCAE v5.0 grade ≥2 bleeding events throughout the stem-cell mobilization cycle.
Nadir platelet count
The minimum peripheral platelet count observed in mobilization cycle.
Duration of platelet count <20 ×10⁹/L
Number of days with platelet count below 20 ×10⁹/L.
Proportion of participants with delayed stem-cell apheresis due to severe thrombocytopenia
Percentage of subjects whose apheresis is postponed because of severe thrombocytopenia.
Stem-cell mobilization success rate
Proportion of participants achieving total CD34⁺ cell yield ≥5 ×10⁶/kg body weight.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
