Biomarker for Infection Risk in CLL and MM

Mass General Brigham

Status: Active, not recruiting

Conditions: Multiple Myeloma; Chronic Lymphocytic Leukemia

Treatments: Other: Screening

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05844033

23-105

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Chronic Lymphocytic Leukemia and Multiple Myeloma Participants

Description:

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.

Treatment:

Other: Screening