Identifying infection risk biomarkers in blood for CLL and MM patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.