Biomarker for Infection Risk in CLL and MM

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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. Takeda is supporting this research study by providing funding.

Official Title
-----------------
Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma

Conditions
-----------------
Multiple Myeloma, Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Other: Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18 years of age. Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma by WHO criteria. Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant. Exclusion Criteria: Subjects must not have received IVIG administration within 6 calendar months of registration or have planned IVIG infusion by treating investigator at time of registration. Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage 0. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Lymphocytic Leukemia and Multiple Myeloma Participants<br>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. | Other: Screening<br>* Blood tests<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of All-Grade Infections For All Participants | Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for all participants. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Grade ≥3 Infections For All Participants | Defined as the number of Grade ≥3 infections per person-years per CTCAE version 5.0 for all participants. | up to 2 years | 
| Number of All-Grade Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) Participants | Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for CLL/SLL participants. | Up to 2 years | 
| Number of Grade ≥3 Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Participants | Defined as the number of Grade ≥3 infections per person-years per CTCAE version 5.0 for CLL and SLL participants. | up to 2 years | 
| Number of All-Grade Infections for Multiple Myeloma (MM) Participants | Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for MM participants. | up to 2 years | 
| Number of Grade ≥3 Infections for Multiple Myeloma (MM) Participants | Defined as the number of Grade ≥3 infections per person-years per CTCAE version 5.0 for MM participants. | up to 2 years | 
| Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM. | Defined as any incident in which IVIG is administered to an participant who develops symptomatic hypogammaglobulinemia with IgG <600mg/dL and either 1) ≥2 associated infections within a 6-month period, or 2) any grade ≥3 associated infection. | Up to 2 years | 
| Proportion of patients who develop asymptomatic hypogammaglobulinemia in CLL/SLL or MM. | Defined as the proportion of all participants who develop symptomatic hypogammaglobulinemia. | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Chronic Lymphocytic Leukemia