Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
Launched by MAYO CLINIC · Oct 3, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand why some patients with multiple myeloma or certain types of lymphoproliferative disorders experience low blood cell counts, known as cytopenia, after receiving CAR-T therapy. CAR-T therapy is a treatment that uses modified immune cells to fight cancer, but many patients may have lower than normal blood cells for more than 30 days after the treatment. The researchers will study changes in genes from blood tests to see if these changes can help predict who is at risk for developing cytopenia after treatment.
To participate in this study, you must be at least 18 years old and have a confirmed diagnosis of multiple myeloma or a CD19+ lymphoproliferative disorder. You will need to provide consent and be willing to give samples from your bone marrow, hair follicles, and saliva for research purposes. While the study is not yet recruiting, it aims to help improve understanding of the effects of CAR-T therapy and potentially lead to better care for patients in the future. If you decide to take part, you will need to return to the study site for follow-up visits during the monitoring phase.
Gender
ALL
Eligibility 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
About Mayo Clinic
Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Scottsdale, Arizona, United States
Jacksonville, Florida, United States
Rochester, Minnesota, United States
La Crosse, Wisconsin, United States
Eau Claire, Wisconsin, United States
Albert Lea, Minnesota, United States
Mankato, Minnesota, United States
Patients applied
Trial Officials
Mithun V. Shah, MD
Principal Investigator
Mayo Clinic in Rochester
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported