Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of All-Grade Infections For All Participants
研究概览
简要总结
The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).
详细描述
The goal of this research study is to identify an antigen-specific antibody profiling biomarker associated with increased risk of any infections in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).
Research procedures including screening for eligibility, clinic visits, and blood tests.
This involves performing blood tests which detect antibodies directed against specific pathogens and measure their functional capacity, and collecting information about outcomes in patients.
Participation in this research study is expected to last 2 years.
It is expected that about 150 people CLL or MM will take part in this research study, and this will predominantly include people with CLL/SLL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults ≥18 years of age.
- •Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma.
- •Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant.
排除标准
- •Subjects must not have received IVIG administration within 6 calendar months of registration or have planned immunoglobulin replacement therapy by treating investigator at time of registration.
- •Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage
- •Subjects with multiple myeloma must not have smoldering myeloma or solitary plasmacytoma with or without minimal marrow involvement.
- •Subjects must not have undergone prior autologous, allogeneic stem cell, or solid organ transplant.
- •Subjects must not have any active systemic infection requiring ongoing antimicrobial treatment (prophylactic antimicrobial allowed) at time of registration.
- •Subjects must have no known history of HIV, primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication at time of registration. Treatment for CLL/SLL or MM, CLL/SLL related autoimmune phenomenon, or physiologic dosing of corticosteroids (5mg/day prednisone/equivalent or lower) is permitted.
研究组 & 干预措施
Chronic Lymphocytic Leukemia and Multiple Myeloma Participants
150 participants will be screened for an antigen-specific antibody profiling biomarker that is associated with an increased risk of any infections.
Study procedures include in-person or virtual appointments every 3 months for 2 years, some of which will also include bloodwork:
- In-person or virtual appointments with study staff for months 4, 10, 16, and 22 Day 1.
- In-person or virtual appointments with study staff for months 7, 13, 19, and 25 Day 1 with blood tests.
干预措施: Screening (Other)
结局指标
主要结局
Number of All-Grade Infections For All Participants
时间窗: up to 2 years
Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for all participants.
次要结局
- Number of Grade ≥3 Infections For All Participants(up to 2 years)
- Number of All-Grade Infections for Multiple Myeloma (MM) Participants(up to 2 years)
- Number of Grade ≥3 Infections for Multiple Myeloma (MM) Participants(up to 2 years)
- Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM.(Up to 2 years)
- Proportion of patients who develop asymptomatic hypogammaglobulinemia in CLL/SLL or MM.(Up to 2 years)
- Number of All-Grade Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) Participants(Up to 2 years)
- Number of Grade ≥3 Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Participants(up to 2 years)
研究者
Jacob Soumerai, MD
Principal Investigator
Massachusetts General Hospital