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

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: Recruiting
• Conditions: Lymphoma; Multiple Myeloma
• Intervention / Treatment: Drug: Etoposide; Drug: Mecapegfilgrastim, day 2; Drug: Mecapegfilgrastim, day 5; Drug: Cyclophosphamide

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • Peking University Third Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Cancer Hospital
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Shandong Cancer Hospital
      • Contact: Zengjun Li
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital
    • Tianjin, Tianjin, China
      • Not yet recruiting
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Yafei Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of the total CD34+ cells	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	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)	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	times to neutrophil and platelet engraftment after autologous stem cell transplantation	up to 1 year post-transplantation

Collaborators and Investigators

• Sponsor: Qiu Lugui
• Collaborators: Jiangsu Hengrui Pharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2022
• Primary Completion (ANTICIPATED): March 31, 2024
• Study Completion (ANTICIPATED): September 30, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (ACTUAL): March 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; peripheral blood stem cell mobilization; Mecapegfilgrastim
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Cyclophosphamide; Etoposide
• Other Study ID Numbers: MA-ASCT-II-002

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