MC230818 Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy UNEXPLAINED CYTOPENIA POST-CAR-T CELL THERAPY

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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
* 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 samples for correlative research

Exclusion Criteria:

* Ineligible for CAR-T therapy
* Patients diagnosed with myeloid neoplasm before CAR-T therapy

Additional Trial Information

Enrollment: 82 patients (estimated)

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Trial Locations

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View all clinical trial locations sorted by state.

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Minnesota

Mayo Clinic Health System

Albert Lea, MN

Open and Accepting

Mayo Clinic Health Systems-Mankato

Mankato, MN

Open and Accepting

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Wisconsin

Mayo Clinic Health System - Clairemont

Eau Claire, WI

Open and Accepting

Mayo Clinic Health System (La Crosse)

La Crosse, WI

Open and Accepting
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