Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma

Last updated: May 12, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer/tumors

Lymphoproliferative Disorders

Treatment

Mecapegfilgrastim, day 5

Etoposide

Mecapegfilgrastim, day 2

Clinical Study ID

NCT05294055
IIT2021036
  • Ages 18-65
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myelomawith 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 clinicalstudy period and for 90 days after the last dose and have a negative serologicalpregnancy test within 72 hours prior to the first dose.

  8. Patients must be able and willing to give written informed consent prior to anystudy-related procedures

Exclusion

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% bonemarrow involvement at screening ;

  4. Patients with angina pectoris, myocardial infarction, coronary stent implantation,uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistentventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval >500ms, leftventricular ejection fraction (EF)<60%, or other heart diseases that theinvestigator considers unsuitable for hematopoietic stem cell mobilization orhematopoietic stem cell transplantation;

  5. Patients with uncontrolled pulmonary infection;

  6. Patients who had any of the following laboratory indicators:

  7. White blood cell count(WBC)<2.5×109/L;

  8. Absolute neutrophil count(ANC)<1.5×109/L;

  9. Platelets count(PLT)<80×109/L;

  10. Creatinine > 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min

  11. AST/ALT/Total bilirubin > 2.5 X ULN;

  12. Patients who have received any of the following treatments:

  13. Patients who had been treated with more than 4 cycles of lenalidomide orreceived lenalidomide within 4 weeks prior to hematopoietic stem cellmobilization chemotherapy.

  14. Patients who previously been treated with fludarabine or melphalan;

  15. Patients who plan to receive radiation within 30 days after transplantation

  16. Patients who had received radiation therapy in the pelvis

  17. Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor,granulocyte stimulating factor, or other formulations expressed by E. coli.

  18. Patients who are pregnant or breastfeeding

  19. Patients who are participating in other clinical studies or the interval of the lastdose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5half-lives of the study drug);

  20. Patients with other conditions unsuitable for this study according to theinvestigator's judgment.

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Mecapegfilgrastim, day 5
Phase: 2
Study Start date:
April 26, 2022
Estimated Completion Date:
September 30, 2026

Study Description

Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to the protocol, high-dose cyclophosphamide (50mg/kg or 2g/m2, for 2 days) is given to patients with MM, and high-dose etoposide (1.5-1.8g/m2, single dose ) is administered to patients with lymphoma. Apheresis is performed according to the standard institutional regulations. The primary point is to evaluate the percentage of successful mobilization, defined as the cumulative collection of ≥2×10^6/kg CD34+ cells in three or fewer apheresis.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Site Not Available

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