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
Overview
- Phase
- Phase 2
- Intervention
- Etoposide
- Conditions
- Multiple Myeloma
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Enrollment
- 120
- Locations
- 7
- Primary Endpoint
- percentage of successful mobilization
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
Intervention: Etoposide
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
Intervention: Mecapegfilgrastim, day 2
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
Intervention: Etoposide
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
Intervention: Mecapegfilgrastim, day 5
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
Intervention: Cyclophosphamide
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
Intervention: Mecapegfilgrastim, day 2
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
Intervention: Cyclophosphamide
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
Intervention: Mecapegfilgrastim, day 5
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- the number of the total CD34+ cells(up to 28 days since the last subject were given mecapegfilgrastim)