Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma
A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma
1 other identifier
interventional
120
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Apr 2022
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedStudy Start
First participant enrolled
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedMay 13, 2025
May 1, 2025
3.9 years
March 15, 2022
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of successful mobilization
The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected.
up to 28 days since the last subject were given mecapegfilgrastim
Secondary Outcomes (4)
the number of the total CD34+ cells
up to 28 days since the last subject were given mecapegfilgrastim
the number of leukaphereses
up to 28 days since the last subject were given mecapegfilgrastim
Incidence of febrile neutropenia (FN)
up to 28 days since the last subject were given mecapegfilgrastim
times to neutrophil and platelet engraftment
up to 1 year post-transplantation
Study Arms (4)
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
EXPERIMENTALlymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
EXPERIMENTALmyltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
EXPERIMENTALmyltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
EXPERIMENTALInterventions
Etoposide 1.5-1.8g/m2, single dose
Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy
Eligibility Criteria
You may qualify if:
- Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
- Patients who had achieved at least partial response (PR);
- Patients who were eligible for autologous peripheral blood stem cell transplantation
- Age≥18 and≤65 years;
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients who have an estimated life expectancy of more than three months
- 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.
- Patients must be able and willing to give written informed consent prior to any study-related procedures
You may not qualify if:
- Patients who had previously attempted hematopoietic stem cell mobilization;
- Patients who had undergone previous bone marrow transplantation;
- Lymphoma patients with bone marrow involvement or patients with MM who had \>10% bone marrow involvement at screening ;
- 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;
- Patients with uncontrolled pulmonary infection;
- Patients who had any of the following laboratory indicators:
- White blood cell count(WBC)\<2.5×109/L；
- Absolute neutrophil count(ANC)\<1.5×109/L；
- Platelets count(PLT)\<80×109/L；
- Creatinine \> 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min
- AST/ALT/Total bilirubin \> 2.5 X ULN；
- Patients who have received any of the following treatments:
- 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.
- Patients who previously been treated with fludarabine or melphalan;
- Patients who plan to receive radiation within 30 days after transplantation
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Shandong Cancer Hospital
Jinan, Shandong, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 24, 2022
Study Start
April 26, 2022
Primary Completion
March 31, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share