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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Etoposide
  Etoposide 1.5-1.8g/m2, single dose
• Препарат Cyclophosphamide
  Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
• Препарат Mecapegfilgrastim, day 2
  Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
• Препарат Mecapegfilgrastim, day 5
  Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy

Первичные конечные точки

• percentage of successful mobilization [Срок оценки: up to 28 days since the last subject were given mecapegfilgrastim]

Вторичные конечные точки (4)

• the number of the total CD34+ cells [Срок оценки: up to 28 days since the last subject were given mecapegfilgrastim]
• the number of leukaphereses [Срок оценки: up to 28 days since the last subject were given mecapegfilgrastim]
• Incidence of febrile neutropenia (FN) [Срок оценки: up to 28 days since the last subject were given mecapegfilgrastim]
• times to neutrophil and platelet engraftment [Срок оценки: up to 1 year post-transplantation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Anhui Provincial Hospital — Хэфэй
• Peking University Third Hospital — Пекин
• Henan Cancer Hospital — Чжэнчжоу
• Shandong Cancer Hospital — Цзинань
• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь
• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь
• Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT05294055 · IIT2021036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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