Biomarker for Infection Risk in CLL and MM

NCT05844033 | Active Not Recruiting

• 1 other identifier: 23-105
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma; Chronic Lymphocytic Leukemia

Keywords

Multiple Myeloma; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Grade ≥3 Infections For All Participants

  up to 2 years

• Number of All-Grade Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) Participants

  Up to 2 years

• Number of Grade ≥3 Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Participants

  up to 2 years

• Number of All-Grade Infections for Multiple Myeloma (MM) Participants

  up to 2 years

• Number of Grade ≥3 Infections for Multiple Myeloma (MM) Participants

  up to 2 years

Study Arms (1)

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

Interventions

Screening OTHER

Blood tests

Chronic Lymphocytic Leukemia and Multiple Myeloma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Antibody profiling and functional assays (advanced testing which detects antibodies directed against specific pathogens and measures their functional capacity)

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Jacob Soumerai, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation.

Locations

US (1)