Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
MC230818 Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy
Mayo Clinic
82 participants
Nov 22, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Age ≥ 18 years
- 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
- Provide written informed consent
- Willingness to provide mandatory bone marrow aspirate specimens for correlative research. All bone marrow aspirate samples are collected during a clinical procedure
- Willingness to provide mandatory hair follicle specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willingness to provide saliva and buccal samples for research
Exclusion Criteria2
- Ineligible for CAR-T therapy
- Patients diagnosed with myeloid neoplasm before CAR-T therapy
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Undergo hair, buccal, and saliva sample collection
Undergo bone marrow aspiration
Ancillary studies
Undergo CFU
Receive genetic counselor consultation
Undergo sequencing analysis
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06630104