Biomarker for Infection Risk in CLL and MM

Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma; Chronic Lymphocytic Leukemia
• Intervention / Treatment: Other: Screening

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diagnoses of Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Multiple Myeloma.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Screening; Blood tests

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 asymptomatic hypogammaglobulinemia in CLL/SLL or MM.	Defined as the proportion of all participants who develop symptomatic hypogammaglobulinemia.	Up to 2 years
Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM.	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.	Up to 2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Takeda
• Investigators: Principal Investigator: Jacob Soumerai, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Chronic Lymphocytic Leukemia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Mass Screening
• Other Study ID Numbers: 23-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No