Understanding blood cell issues after CAR-T therapy for multiple myeloma or lymphoproliferative disorders
MC230818 Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy
NA · Mayo Clinic · NCT06630104
This study is testing how certain genetic differences in people with multiple myeloma or lymphoproliferative disorders affect their chances of developing low blood cell counts after CAR-T therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 7 sites (Scottsdale, Arizona and 6 other locations) |
| Trial ID | NCT06630104 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how genetic variations in patients with multiple myeloma or CD19 positive lymphoproliferative disorder affect the risk of developing cytopenia after receiving CAR-T therapy. The study involves collecting bone marrow, hair, buccal, and saliva samples to analyze preexisting and therapy-emergent genetic variants. Patients will be monitored for cytopenia and undergo follow-up assessments for up to two years to evaluate the impact of these genetic factors. The goal is to identify gene mutations that may help predict the risk of prolonged cytopenia following treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed multiple myeloma or CD19 positive lymphoproliferative disorder who are eligible for CAR-T therapy.
Not a fit: Patients who are ineligible for CAR-T therapy or have a prior diagnosis of myeloid neoplasm may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for patients undergoing CAR-T therapy.
How similar studies have performed: While this approach is novel in its focus on genetic variants related to cytopenia post-CAR-T therapy, similar studies have shown promise in understanding genetic influences on treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona and 6 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (RECRUITING)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (RECRUITING)
- Mayo Clinic Health System-Mankato — Mankato, Minnesota, United States (RECRUITING)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
- Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States (RECRUITING)
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Mithun V. Shah, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoproliferative Disorder, Multiple Myeloma