Biomarker for Infection Risk in CLL and MM (NCT05844033) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Biomarker for Infection Risk in CLL and MM
United States150 participantsStarted 2023-08-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is actively enrolling but no longer recruiting — does that mean the data collection is still ongoing, and if so, could it still be relevant to understanding my infection risks as someone with CLL or multiple myeloma?
2Since the study is focused on tracking infections across all grades in patients with CLL and MM, could the findings help identify a biomarker that might one day predict my personal risk of getting serious infections during treatment?
3Infections are a major concern with both CLL and multiple myeloma — based on what's already known from studies like this one, are there steps my care team would recommend now to help reduce my infection risk while I'm on treatment?
4This trial doesn't appear to involve an experimental treatment — it seems to be observational — so how does that change the risk or benefit picture compared to a trial testing a new drug, and is there any reason my doctor might want me involved or aware of its results?
5Could the biomarker findings from this study eventually change how my doctor monitors me for infections, and when might results from research like this realistically make their way into everyday clinical care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of All-Grade Infections For All Participants