MC230818 Understanding The Mechanisms Of Clonal And Non-clonal Cytopenia Following CAR-T Therapy

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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 Criteria:

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/28/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Mithun Shah, M.D., Ph.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Jacksonville, Fla. Mayo Clinic principal investigator Talha Badar, M.B.B.S., M.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
La Crosse, Wis. Mayo Clinic principal investigator Anna Jones, M.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Mankato, Minn. Mayo Clinic principal investigator Amrit Singh, M.B.B.S.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Cecilia Arana Yi, M.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Eau Claire, Wis. Mayo Clinic principal investigator Eyad Al-Hattab, M.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Albert Lea, Minn. Mayo Clinic principal investigator Mina Hanna, M.D.	Contact us for the latest status	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials