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

May 12, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Zimin Sun
        • Principal Investigator:
          • Zimin Sun
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Hongmei Jing
        • Contact:
          • Hongmei Jing
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Baijun Fang
        • Contact:
          • Baijun Fang
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Zengjun Li
        • Principal Investigator:
          • Zengjun Li
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:
        • Principal Investigator:
          • Lugui Qiu, MD
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Rong Fu
        • Contact:
          • Rong Fu
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Yafei Wang
        • Principal Investigator:
          • Yafei Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
Drug: Etoposide
Etoposide 1.5-1.8g/m2, single dose
Drug: Mecapegfilgrastim, day 2
Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
Drug: Etoposide
Etoposide 1.5-1.8g/m2, single dose
Drug: Mecapegfilgrastim, day 5
Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
Drug: Mecapegfilgrastim, day 2
Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Drug: Cyclophosphamide
Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
Drug: Mecapegfilgrastim, day 5
Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy
Drug: Cyclophosphamide
Cyclophosphamide 50mg/kg or 2g/m2, for 2 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
percentage of successful mobilization
Time Frame: up to 28 days since the last subject were given mecapegfilgrastim
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the number of the total CD34+ cells
Time Frame: up to 28 days since the last subject were given mecapegfilgrastim
the number of the total CD34+ cells which were collected from each subject
up to 28 days since the last subject were given mecapegfilgrastim
the number of leukaphereses
Time Frame: up to 28 days since the last subject were given mecapegfilgrastim
the number of leukaphereses needed to collect ≥2×10^6/kg CD34+ cells
up to 28 days since the last subject were given mecapegfilgrastim
Incidence of febrile neutropenia (FN)
Time Frame: up to 28 days since the last subject were given mecapegfilgrastim
incidence of FN during chemotherapy plus mecapegfilgrastim mobilization
up to 28 days since the last subject were given mecapegfilgrastim
times to neutrophil and platelet engraftment
Time Frame: up to 1 year post-transplantation
times to neutrophil and platelet engraftment after autologous stem cell transplantation
up to 1 year post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2021036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings