Identifying infection risk biomarkers in blood for CLL and MM patients
Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma
This study is testing a new blood test to see if it can help predict infection risk for people with Chronic Lymphocytic Leukemia (CLL) or Multiple Myeloma (MM).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05844033 on ClinicalTrials.gov |
What this trial studies
This research aims to develop a precise blood test that predicts infection risk in patients diagnosed with Chronic Lymphocytic Leukemia (CLL) or Multiple Myeloma (MM). The study will utilize advanced immunology laboratory analyses to identify antigen-specific antibody profiles associated with increased infection risk. Participants will undergo blood tests to detect antibodies against specific pathogens and assess their functional capacity, alongside regular clinic visits to monitor outcomes. The study is expected to enroll around 150 participants over a duration of two years.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of Rai stage I-IV CLL or MM.
Not a fit: Patients with Rai stage 0 CLL or smoldering myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infection risk management in patients with CLL and MM.
How similar studies have performed: While similar approaches have been explored, this specific biomarker identification for infection risk in CLL and MM is a novel endeavor.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jacob Soumerai, MD — Massachusetts General Hospital
- Study coordinator: Jacob Soumerai, MD
- Email: jsoumerai@mgh.harvard.edu
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.