ACTIVE_NOT_RECRUITING

Biomarker for Infection Risk in CLL and MM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma

Quick Facts

Study Start:2023-08-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05844033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥18 years of age.
  2. * Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma.
  3. * Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant.
  1. * 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.
  2. * Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage 0.
  3. * Subjects with multiple myeloma must not have smoldering myeloma or solitary plasmacytoma with or without minimal marrow involvement.
  4. * Subjects must not have undergone prior autologous, allogeneic stem cell, or solid organ transplant.
  5. * Subjects must not have any active systemic infection requiring ongoing antimicrobial treatment (prophylactic antimicrobial allowed) at time of registration.
  6. * 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.

Contacts and Locations

Principal Investigator

Jacob Soumerai, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Jacob Soumerai, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia