A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation

Washington University School of Medicine1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2015年1月20日最近更新: 2019年11月26日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Washington University School of Medicine
入组人数: 90
试验地点: 1
主要终点: Number of Participants With Complete Response or Stringent Complete Response

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple myeloma cells move from the patient's bone marrow to the blood where they may be more sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Symptomatic multiple myeloma requiring treatment
•Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy
•At least 18 years of age
•Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 × 10^6 CD34+ cells/kg based on patient body weight.
•Adequate organ function as measured by:
•Cardiac function: Left ventricular ejection fraction at rest ≥40%
•Hepatic function: Bilirubin ≤2 × ULN and aspartate amino transferase/alanine amino transferase (AST/ALT) ≤3 × ULN
•Renal function: Creatinine clearance ≥40 mL/minute (measured or calculated/estimated)
•Pulmonary function: Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin [Hgb]), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC) ≥50% of predicted value
•Oxygen saturation ≥92% on room air
•Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or
•Able to understand and willing to sign an IRB-approved written informed consent document

排除标准

•Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to ASCT
•Prior stem cell transplant (autologous or allogeneic)
•Smoldering MM not requiring therapy
•Plasma cell leukemia
•Systemic amyloid light chain amyloidosis
•Active bacterial, viral, or fungal infection
•Seropositive for human immunodeficiency virus (HIV)
•Known, active hepatitis A, B, or C Infection
•Pregnant or breastfeeding.
•Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on Day +
•Hypersensitive or intolerant to any component of the study drug(s) formulation
•Receiving growth factors (filgrastim, XM02-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis < 14 days prior to the start of treatment on protocol (Day -7).