Biomarker for Infection Risk in CLL and MM

Multiple Myeloma Clinical Trial

Official title:

Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844033
• Other study ID #: 23-105
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Jacob Soumerai, MD
• Phone: 617-724-4000
• Email: jsoumerai[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Screening
Blood tests

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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