RecruitingNot ApplicableNCT06630104

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


Sponsor

Mayo Clinic

Enrollment

82 participants

Start Date

Nov 22, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at why some patients develop low blood cell counts (a condition called cytopenia) after receiving CAR-T cell therapy — a cutting-edge immunotherapy — for multiple myeloma or certain lymphomas. Researchers hope to understand the underlying causes to prevent or treat this side effect. **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma or a type of lymphoma (CD19+) - You are scheduled to receive or have already received CAR-T cell therapy - You are willing to provide bone marrow, hair follicle, saliva, and cheek swab samples for research **You may NOT be eligible if...** - You are not eligible for CAR-T therapy - You were diagnosed with a myeloid blood cancer before CAR-T therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo hair, buccal, and saliva sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

OTHERElectronic Health Record Review

Ancillary studies

PROCEDUREFollow-Up

Undergo CFU

OTHERGenetic Counseling

Receive genetic counselor consultation

OTHERGenetic Testing

Undergo sequencing analysis


Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT06630104


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