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

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT06630104

Registry updated: 2026-10-01

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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.

Interventions

Biospecimen Collection (Procedure)
Undergo hair, buccal, and saliva sample collection
Bone Marrow Aspiration (Procedure)
Undergo bone marrow aspiration
Electronic Health Record Review (Other)
Ancillary studies
Follow-Up (Procedure)
Undergo CFU
Genetic Counseling (Other)
Receive genetic counselor consultation
Genetic Testing (Other)
Undergo sequencing analysis

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

Conditions

Lymphoproliferative Disorder Multiple Myeloma

Locations

Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States
Mayo Clinic Health System-Mankato — Mankato, Minnesota, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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