A Phase 2/3 interventional study of rhTPO prophylaxis plus EAP stem-cell mobilization in Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Hematopoietic Stem Cell Mobilization and Chemotherapy-Induced Thrombocytopenia, sponsored by The Affiliated People's Hospital of Ningbo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 2/3, Interventional, and Treatment
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.
Exclusion Criteria:
This is the only interventional arm of this multicenter, prospective, single-arm phase II study. Eligible patients with lymphoma or multiple myeloma receive standard EAP mobilization chemotherapy (etoposide 75 mg/m² i.v. d1-2, cytarabine 200 mg/m² q12h i.v. d1-2; pegfilgrastim is administered subcutaneously on day 6 after completion of chemotherapy; dose reduction to 2/3-3/4 of original dose is allowed for patients \> 65 years or creatinine clearance 30-60 mL/min). After EAP chemotherapy, blood routine tests are monitored dynamically. When peripheral platelet count drops to ≤ 80 × 10⁹/L, \*\*prophylactic recombinant human thrombopoietin (rhTPO) 300 U/kg is given subcutaneously once daily\*\*. rhTPO administration continues until completion of stem-cell apheresis, platelet recovery \> 50 × 10⁹/L, or investigator-judged discontinuation. Platelet transfusion is only permitted when platelet count \< 20 × 10⁹/L or active bleeding occurs. Subjects undergo serial laboratory assessments including
Drug: rhTPO prophylaxis plus EAP stem-cell mobilization
Standard 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.
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.
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.
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.
Nadir platelet count
The minimum peripheral platelet count observed in mobilization cycle.
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis, assessed up to 40 days.
Duration of platelet count <20 ×10⁹/L
Number of days with platelet count below 20 ×10⁹/L.
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.
Proportion of participants with delayed stem-cell apheresis due to severe thrombocytopenia
Percentage of subjects whose apheresis is postponed because of severe thrombocytopenia.
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.
Stem-cell mobilization success rate
Proportion of participants achieving total CD34⁺ cell yield ≥5 ×10⁶/kg body weight.
Time frame: At completion of stem-cell apheresis,assessed up to 30 days.
Incidence of adverse events
Incidence of thromboembolism, liver injury, severe bone pain, severe infection graded by CTCAE v5.0.
Time frame: From start of study intervention to completion of stem-cell collection, assessed up to 40 days.
Length of hospital stay during mobilization
Total hospital days in the mobilization stage.
Time frame: From admission for EAP mobilization to discharge after apheresis finished,assessed up to 30 days.
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated People's Hospital of Ningbo University