NCT06630104Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 3 Oct 2024
- Start date
- 22 Nov 2024
- Primary completion date
- 16 Dec 2029
- Lead sponsor
- Mayo Clinic
- Diseases
- Multiple myeloma
- NCT number
- NCT06630104
What you commit to
- Study type: Interventional
- Planned participants: 82
- From 22 Nov 2024 to the primary completion date, 16 Dec 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ineligible for CAR-T therapy
- Patients diagnosed with myeloid neoplasm before CAR-T therapy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Health System in Albert Lea Coordinator of this site? Confirm its status | Albert Lea | United States | Recruiting |
| Mayo Clinic Health System-Eau Claire Clinic Coordinator of this site? Confirm its status | Eau Claire | United States | Recruiting |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Mayo Clinic Health System-Franciscan Healthcare Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| Mayo Clinic Health System Mankato Coordinator of this site? Confirm its status | Mankato | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.