Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2022-04-26
Last updated
2025-05-13
Condition(s) studied
Multiple MyelomaLymphoma
Investigational drug(s) / intervention(s)
EtoposideCyclophosphamideMecapegfilgrastim, day 2Mecapegfilgrastim, day 5
Etoposide: Etoposide 1.5-1.8g/m2, single dose
Cyclophosphamide: Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
Mecapegfilgrastim, day 2: Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Mecapegfilgrastim, day 5: Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy
Study summary
This is a multicenter prospective study to evaluate the efficacy and safety of chemotherapy combined with a single dose of subcutaneous(SC) injection mecapegfilgrastim on day 2 or day 5 after chemotherapy for autologous peripheral blood stem cell (PBSC) mobilization in patients with multiple myeloma or lymphoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
2. Patients who had achieved at least partial response (PR);
3. Patients who were eligible for autologous peripheral blood stem cell transplantation
4. Age≥18 and≤65 years;
5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Patients who have an estimated life expectancy of more than three months
7. Fertile patients must be willing to use reliable contraception during the clinical study period and for 90 days after the last dose and have a negative serological pregnancy test within 72 hours prior to the first dose.
8. Patients must be able and willing to give written informed consent prior to any study-related procedures
Exclusion Criteria:
1. Patients who had previously attempted hematopoietic stem cell mobilization;
2. Patients who had undergone previous bone marrow transplantation;
3. Lymphoma patients with bone marrow involvement or patients with MM who had \>10% bone marrow involvement at screening ;
4. Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval \>500ms, left ventricular ejection fraction (EF)\<60%, or other heart diseases that the investigator considers unsuitable for hematopoietic stem cell mobilization or hematopoietic stem cell transplantation;
5. Patients with uncontrolled pulmonary infection;
6. Patients who had any of the following laboratory indicators:
1. White blood cell count(WBC)\<2.5×109/L;
2. Absolute neutrophil count(ANC)\<1.5×109/L;
3. Platelets count(PLT)\<80×109/L;
4. Creatinine \> 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min
5. AST/ALT/Total bilirubin \> 2.5 X ULN;
7. Patients who have received any of the following treatments:
1. Patients who had been treated with more than 4 cycles of lenalidomide or received lenalidomide within 4 weeks prior to hematopoietic stem cell mobilization chemotherapy.
2. Patients who previously been treated with fludarabine or melphalan;
3. Patients who plan to receive radiation within 30 days after transplantation
4. Patients who had received radiation therapy in the pelvis
8. Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli.
9. Patients who are pregnant or breastfeeding
10. Patients who are participating in other clinical studies or the interval of the last dose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5 half-lives of the study drug);
11. Patients with other conditions unsuitable for this study according to the investigator's judgment.
Primary outcome measure(s)
percentage of successful mobilization — up to 28 days since the last subject were given mecapegfilgrastim The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected.
Trial sites (7)
Facility
City
Region
Status
Anhui Provincial Hospital
Hefei
Anhui
Not Yet Recruiting
Peking University Third Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Not Yet Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin
Tianjin Municipality
Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Recruiting
Tianjin Medical University General Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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