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).
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.
Study Type
OBSERVATIONAL
Enrollment
150
Blood tests
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
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.
Time frame: up to 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 2 years
Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM.
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Defined as any incident in which immunoglobulin replacement therapy is administered to an participant who develops symptomatic hypogammaglobulinemia with Immunoglobulin G \<600mg/dL and either 1) ≥2 associated infections within a 6-month period, or 2) any grade ≥3 associated infection.
Time frame: 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.
Time frame: Up to 2 years