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Trial Title:
Biomarker for Infection Risk in CLL and MM
NCT ID:
NCT05844033
Condition:
Multiple Myeloma
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Keywords:
Multiple Myeloma
Chronic Lymphocytic Leukemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Screening
Description:
Blood tests
Arm group label:
Chronic Lymphocytic Leukemia and Multiple Myeloma Participants
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.
Criteria for eligibility:
Study pop:
Diagnoses of Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Multiple
Myeloma.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jacob Soumerai, MD
Phone:
617-724-4000
Email:
jsoumerai@mgh.harvard.edu
Start date:
August 1, 2023
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
Takeda
Agency class:
Industry
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844033
