Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaPhase 2/3NCT07848672
Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization
A Phase 2/3 study testing rhTPO prophylaxis plus EAP stem-cell mobilization in people with Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma and Hematopoietic Stem Cell Mobilization, run by The Affiliated People's Hospital of Ningbo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Hematopoietic Stem Cell Mobilization, Chemotherapy-Induced Thrombocytopenia
- What is being tested?
- rhTPO prophylaxis plus EAP stem-cell mobilization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willing and able to complete the full-study follow-up procedures.
- Voluntarily provide written informed consent.
Who cannot join
- 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.
- Pregnant or lactating female subjects.
- Known hypersensitivity to recombinant human thrombopoietin (rhTPO).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Early Prophylactic rhTPO for the Prevention of Hematopoietic Stem Cell Mobilization-Related Thrombocytopenia During the EAP Regimen
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.
- Conditions
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Hematopoietic Stem Cell Mobilization, Chemotherapy-Induced Thrombocytopenia
- Being tested
- rhTPO prophylaxis plus EAP stem-cell mobilization
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPO prophylaxis plus EAP stem-cell mobilizationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic early-use rhTPO for chemotherapy-induced thrombocytopenia during EAP-based hematopoieti | Experimental | 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 Receives: Drug: rhTPO prophylaxis plus EAP stem-cell mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet transfusion rate during mobilization period
Proportion of participants receiving at least one platelet transfusion in the mobilization phase.
Measured: 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.
Measured: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.
Secondary outcomes (6)
Nadir platelet count
The minimum peripheral platelet count observed in mobilization cycle.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission for EAP mobilization to discharge after apheresis finished,assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848672
- Sponsor's protocol ID
- 2026-EAP-1
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Early Prophylactic rhTPO for the Prevention of Hematopoietic Stem Cell Mobilization-Related Thrombocytopenia During the EAP Regimen
- ClinicalTrials.gov ID
- NCT07848672
- Acronym / sponsor ID
- 2026-EAP-1
- Conditions
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Hematopoietic Stem Cell Mobilization, Chemotherapy-Induced Thrombocytopenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Affiliated People's Hospital of Ningbo UniversityOther government
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic early-use rhTPO for chemotherapy-induced thrombocytopenia during EAP-based hematopoieti | Experimental | Drug: rhTPO prophylaxis plus EAP stem-cell mobilizationThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Willing and able to complete the full-study follow-up procedures.
Key exclusion criteria (6 listed)
- 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.
- Pregnant or lactating female subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPO prophylaxis plus EAP stem-cell mobilizationStandard 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. | Drug | Prophylactic early-use rhTPO for chemotherapy-induced thrombocytopenia during EAP-based hematopoieti |
Primary outcome
Platelet transfusion rate during mobilization period
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.
Proportion of participants receiving at least one platelet transfusion in the mobilization phase.
Incidence of grade ≥2 bleeding events during mobilization period
Time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.
Proportion of participants experiencing CTCAE v5.0 grade ≥2 bleeding events throughout the stem-cell mobilization cycle.
6 secondary outcomes
Nadir platelet count
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
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
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
Time frame: At completion of stem-cell apheresis,assessed up to 30 days.
Incidence of adverse events
Time frame: From start of study intervention to completion of stem-cell collection, assessed up to 40 days.
Length of hospital stay during mobilization
Time frame: From admission for EAP mobilization to discharge after apheresis finished,assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rhTPO prophylaxis plus EAP stem-cell mobilization in people with Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma and Hematopoietic Stem Cell Mobilization, run by The Affiliated People's Hospital of Ningbo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxiao Wang (13486889847, 799161574@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet transfusion rate during mobilization period (time frame: From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.