Clinical trial · Observational
Biomarker for Infection Risk in CLL and MM
Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma
NCT05844033CI-TRIAL-00111983active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Chronic Lymphocytic Leukemia and Multiple Myeloma Participants
- description
- 150 participants will be screened for an antigen-specific antibody profiling biomarker that is associated with an increased risk of any infections. Study procedures include in-person or virtual appointments every 3 months for 2 years, some of which will also include bloodwork: * In-person or virtual appointments with study staff for months 4, 10, 16, and 22 Day 1. * In-person or virtual appointments with study staff for months 7, 13, 19, and 25 Day 1 with blood tests.
- interventionNames
- Other: Screening
Primary outcomes (1)
- measure
- Number of All-Grade Infections For All Participants
- timeFrame
- up to 2 years
- description
- Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for all participants.
Secondary outcomes (7)
- measure
- Number of Grade ≥3 Infections For All Participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.