A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation

University of Nebraska1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2020年1月9日最近更新: 2024年3月12日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: University of Nebraska
入组人数: 8
试验地点: 1
主要终点: Number of Safely Treated Participants (Feasibility and Safety)

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 pilot randomized Phase II trial (10 subjects per arm) will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion collected prior to G-CSF mobilization. All subjects will receive tetanus vaccines pre and post-transplant. The primary end point will be tetanus vaccine immune responses post-transplant.

详细描述

PRIMARY OBJECTIVES:

To compare the cellular and humoral vaccine response post-transplant between the two arms by performing Elisa, and T-cell enzyme-linked immunospot (ELISPOT) assays
To determine the feasibility and safety of this approach

SECONDARY OBJECTIVES:

To compare post-transplant recovery of innate and adaptive immune cells (CD8, CD4, CD19, NK, γδ T-cells), in addition to T-cell phenotype markers between the two arms.
To compare post-transplant recovery of T-regs and MDSCs between the two arms.
To compare progression free survival (PFS) at 2 years post-transplant

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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 19 years to 70 years old at time of study entry (consent)
•Diagnosis of Multiple Myeloma as per updated International Myeloma Working Group (IMWG) criteria .
•Must have measurable disease defined as: for secretory MM, serum monoclonal protein ≥1.0 g/dL, urine monoclonal protein ≥200 mg/24 hrs, and involved free light chain ≥ 10 mg/dL; or in case of non-secretory MM, bone marrow plasma cell percentage ≥30%.
•Must have standard risk myeloma (see exclusion criterion 4).
•Must have received bortezomib, lenalidomide and dexamethasone (VRd) as a form of induction therapy pre-AHSCT (use of cyclophosphamide, bortezomib and dexamethasone may be allowed for up to 2 weekly doses before initiation of VRd induction, if necessary clinically for cytoreduction)
•Able to understand and sign a consent form.
•Creatinine clearance equal or > 60 ml/min (calculated)
•Ejection fraction equal or > 50% before admission for transplant as per institutional standards. Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months or arrhythmia) need to be cleared by cardiology as per institutional BMT standards.
•Serum bilirubin, ALT, AST less than 3 X upper limit of normal
•FVC, FEV1 or DLCO >50% predicted before admission for transplant as per institutional standards. Patients on home oxygen are not allowed on the protocol.
•No more than 6 months of pre-transplant MM chemotherapy is allowed (from the date of the start of the induction therapy).
•KPS ≥ 70%or ECOG 0-
•Must be eligible to receive Melphalan dose of 200mg/m2
•A female of child-bearing potential, must have two negative urine pregnancy test results within 10 to 14 days prior to starting the first dose of vaccine pre-transplant as a way of ensuring safe transplant planning.

排除标准

•Participation in another clinical study with an investigational product during the last 28 days.
•Prior stem cell transplant (either autologous or allogeneic)
•Creatinine clearance < 60 ml/min (calculated)
•High risk MM defined as those with the following disease, fluorescence in situ hybridization and/or cytogenetic features: del17p, del1p with 1q gain, t(4;14), t(14;16), t(14;20), >1 cytogenetic abnormality on karyotype, hypodiploid, plasma cell leukemia (primary or secondary), or subjects who failed to achieve ≥PR to induction therapy (i.e. VRd) and required salvage induction prior to AHSCT.
•Documented central nervous system or extramedullary disease.
•Significant organ dysfunction deemed to carry inappropriate risk for AHSCT.
•Intention or plans for cyclophosphamide mobilization.
•Known allergic reactions after previous tetanus diphtheria vaccination or had a condition of Guillain Barre Syndrome (GBS)
•Known active hepatitis B, C or HIV infections on initial assessment.
•Enrollment on any other transplant related protocols.