Recruiting

CAR-T Therapy

Sponsor:

Mayo Clinic

Code:

NCT06630104

Conditions

Lymphoproliferative Disorder

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Marrow Aspiration

Electronic Health Record Review

Follow-Up

Genetic Counseling

Study Details

Brief 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.

Conditions

Lymphoproliferative Disorder

Multiple Myeloma

Study ID

NCT06630104

Start date

Nov 22, 2024

Status verified date

Aug, 2026

Completion date

Dec 16, 2027

Anticipated

Primary completion date

Dec 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

82 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (bone marrow aspiration, CFU)

Patients undergo bone marrow aspiration and hair, saliva, buccal swab, or skin sample collection up to 14 days prior to LD therapy. Patients undergo CFU on day 90 post-CAR-T therapy. Patients with unexplained cytopenia also undergo bone marrow aspiration for sequencing analysis on day 90 and at development of MN-pCT during CFU. Patients also undergo bone marrow aspiration at determination of clonal evolution or myeloid neoplasm if not done during CFU on day 90.

Interventions

Biospecimen Collection

Undergo hair, buccal, and saliva sample collection

Bone Marrow Aspiration

Undergo bone marrow aspiration

Electronic Health Record Review

Ancillary studies

Follow-Up

Undergo CFU

Genetic Counseling

Receive genetic counselor consultation

Genetic Testing

Undergo sequencing analysis

Primary outcome measure

  • Pathogenic and likely pathogenic germline and somatic variants associated with increased risk [ Time Frame: At baseline ]
  • Unexplained cytopenia [ Time Frame: At day 90 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Cecilia Y. Arana Yi, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Talha Badar, MD

Mayo Clinic Health System in Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Mina S. Hanna, MD

Mayo Clinic Health System-Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Amrit B. Singh, MBBS

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Mithun V. Shah, MD, PhD

Mayo Clinic Health System-Eau Claire Clinic

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Eyad S. Al-Hattab, MD

Mayo Clinic Health System-Franciscan Healthcare

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Scott H. Okuno, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-12.