Home › Multiple Myeloma › NCT06630104
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 or skin punch biopsy specimens (skin punch biopsy specimens will be obtained from Mayo Clinic Rochester patients only) for correlative research * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willingness to provide mandatory saliva or buccal swab sample for correlative research Exclusion Criteria: * Ineligible for CAR-T therapy * Patients diagnosed with myeloid neoplasm before CAR-T therapy
About the study
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.
What is being tested
- Biospecimen Collection (procedure)
- Bone Marrow Aspiration (procedure)
- Electronic Health Record Review (other)
- Follow-Up (procedure)
- Genetic Counseling (other)
- Genetic Testing (other)
Sponsor: Mayo Clinic · Participants: 82 · Started: Nov 22, 2024
Contact the study team
- Clinical Trials Referral Office · Phone: 855-776-0015
Official record on ClinicalTrials.gov — NCT06630104
Locations in the U.S.
| Arizona | Mayo Clinic in Arizona, Scottsdale |
| Florida | Mayo Clinic in Florida, Jacksonville |
| Minnesota | Mayo Clinic Health System in Albert Lea, Albert Lea Mayo Clinic Health System-Mankato, Mankato Mayo Clinic in Rochester, Rochester |
| Wisconsin | Mayo Clinic Health System-Eau Claire Clinic, Eau Claire Mayo Clinic Health System-Franciscan Healthcare, La Crosse |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.