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

Sponsor

Qiu Lugui (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05294055

Collaborator

Jiangsu Hengrui Pharmaceuticals Co.,Ltd (Other)

120

Enrollment

Locations

Arms

30.2

Anticipated Duration (Months)

17.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Lymphoma	Drug: Etoposide Drug: Cyclophosphamide Drug: Mecapegfilgrastim, day 2 Drug: Mecapegfilgrastim, day 5	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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: Cyclophosphamide Cyclophosphamide 50mg/kg or 2g/m2, for 2 days Drug: Mecapegfilgrastim, day 2 Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5	Drug: Cyclophosphamide Cyclophosphamide 50mg/kg or 2g/m2, for 2 days Drug: Mecapegfilgrastim, day 5 Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

the number of the total CD34+ cells [up to 28 days since the last subject were given mecapegfilgrastim]
the number of the total CD34+ cells which were collected from each subject
the number of leukaphereses [up to 28 days since the last subject were given mecapegfilgrastim]
the number of leukaphereses needed to collect ≥2×10^6/kg CD34+ cells
Incidence of febrile neutropenia (FN) [up to 28 days since the last subject were given mecapegfilgrastim]
incidence of FN during chemotherapy plus mecapegfilgrastim mobilization
times to neutrophil and platelet engraftment [up to 1 year post-transplantation]
times to neutrophil and platelet engraftment after autologous stem cell transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Patients who had received radiation therapy in the pelvis
Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli.
Patients who are pregnant or breastfeeding
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);
Patients with other conditions unsuitable for this study according to the investigator's judgment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital	Hefei	Anhui	China
2	Peking University Third Hospital	Beijing	Beijing	China
3	Henan Cancer Hospital	Zhengzhou	Henan	China
4	Shandong Cancer Hospital	Jinan	Shandong	China
5	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin	China	300020
6	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin	China
7	Tianjin Medical University General Hospital	Tianjin	Tianjin	China