Clinical trial NCT05844033: Biomarker for Infection Risk in CLL and MM
Official title: Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Chronic Lymphocytic Leukemia
Keywords: Multiple Myeloma
Chronic Lymphocytic Leukemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2023-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnoses of Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Multiple Myeloma.

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.

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.
* 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 immunoglobulin replacement therapy 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.

Primary outcomes:
measure: Number of All-Grade Infections For All Participants
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of Grade ≥3 Infections For All Participants
timeFrame: up to 2 years
measure: Number of All-Grade Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) Participants
timeFrame: Up to 2 years
measure: Number of Grade ≥3 Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Participants
timeFrame: up to 2 years
measure: Number of All-Grade Infections for Multiple Myeloma (MM) Participants
timeFrame: up to 2 years
measure: Number of Grade ≥3 Infections for Multiple Myeloma (MM) Participants
timeFrame: up to 2 years
measure: Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM.
timeFrame: Up to 2 years
measure: Proportion of patients who develop asymptomatic hypogammaglobulinemia in CLL/SLL or MM.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jacob Soumerai, MD
role: PRINCIPAL_INVESTIGATOR
References: