RECRUITING

Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)

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

This clinical trial evaluates the impact of preexisting and therapy-emergent germline and somatic variants on cytopenia in patients with multiple myeloma or CD19 positive lymphoproliferative disorder (LPD) following chimeric antigen receptor T-cell (CAR-T) therapy. The most common adverse event after CAR-T therapy is lower than normal blood cells (cytopenia) and up to one third of patients experience cytopenia that last longer than 30 days post-infusion. Germline and somatic variants are changes in genes found using cancer genomic tests. Cancer genetic/genomic testing is a series of tests that find specific changes in cancer cells or in blood deoxyribonucleic acid. Identifying gene mutations may help identify the risk of cytopenia in patients with multiple myeloma or CD19 positive LPD following CAR-T therapy.

Official Title

Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy

Quick Facts

Study Start:2024-11-22
Study Completion:2025-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06630104

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. * Age ≥ 18 years
  2. * Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined in International Myeloma Working Group (IMWG) criteria or a CD19+ lymphoproliferative disorder (LPD) as defined by 2016 World Health Organization (WHO) classification
  3. * Provide written informed consent
  4. * Willingness to provide mandatory bone marrow aspirate specimens for correlative research. All bone marrow aspirate samples are collected during a clinical procedure
  5. * Willingness to provide mandatory hair follicle specimens for correlative research
  6. * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  7. * Willingness to provide saliva and buccal samples for research
  1. * Ineligible for CAR-T therapy
  2. * Patients diagnosed with myeloid neoplasm before CAR-T therapy

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Mithun V. Shah, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
United States
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Mithun V. Shah, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

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 Date2024-11-22
Study Completion Date2025-12-16

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2025-12-16

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoproliferative Disorder
  • Multiple Myeloma