Trial Title:
Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
NCT ID:
NCT06630104
Condition:
Lymphoproliferative Disorder
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoproliferative Disorders
Cytopenia
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo hair and saliva sample collection
Arm group label:
Supportive care (bone marrow aspiration, CFU)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspiration
Description:
Undergo bone marrow aspiration
Arm group label:
Supportive care (bone marrow aspiration, CFU)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Supportive care (bone marrow aspiration, CFU)
Intervention type:
Procedure
Intervention name:
Follow-Up
Description:
Undergo CFU
Arm group label:
Supportive care (bone marrow aspiration, CFU)
Other name:
Active Follow-up
Other name:
Clinical Signs Follow-up
Other name:
CLSFUP
Other name:
Follow Up
Other name:
follow_up
Other name:
Followed
Other name:
Followup
Intervention type:
Other
Intervention name:
Genetic Counseling
Description:
Receive genetic counselor consultation
Arm group label:
Supportive care (bone marrow aspiration, CFU)
Intervention type:
Other
Intervention name:
Genetic Testing
Description:
Undergo sequencing analysis
Arm group label:
Supportive care (bone marrow aspiration, CFU)
Other name:
Genetic Analysis
Other name:
Genetic Examination
Other name:
Genetic Test
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.
Detailed description:
PRIMARY OBJECTIVE:
I. Determine the preexisting and therapy-emergent germline and somatic variants
associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell
therapy.
SECONDARY OBJECTIVE:
I. Characterize the baseline transcriptomic signature associated with non-clonal and
clonal cytopenia following CAR-T therapy.
OUTLINE:
Patients undergo bone marrow aspiration and hair and saliva sample collection up to 14
days prior to lymphodepleting (LD) therapy. Patients undergo clinical follow-up (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 myeloid neoplasm
post-cytotoxic therapies (MN-pCT) during CFU. Patients also undergo bone marrow
aspiration at determination of clonal evolution or myeloid neoplasm if not done during on
day 90. Additionally, patients a receive genetic counselor consultation on study.
Patients with unexplained cytopenia at day 90 are followed up every 90 days for up to 2
years until resolution. Patients without unexplained cytopenia are followed clinically
for up to 2 years.
Criteria for 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
- 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 samples for research
Exclusion Criteria:
- Ineligible for CAR-T therapy
- Patients diagnosed with myeloid neoplasm before CAR-T therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Cecilia Y. Arana Yi, MD
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Talha Badar, MD
Facility:
Name:
Mayo Clinic Health System in Albert Lea
Address:
City:
Albert Lea
Zip:
56007
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Mina S. Hanna, MD
Facility:
Name:
Mayo Clinic Health System-Mankato
Address:
City:
Mankato
Zip:
56001
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Amrit B. Singh, MBBS
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Mithun V. Shah, MD, PhD
Facility:
Name:
Mayo Clinic Health System-Eau Claire Clinic
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Eyad S. Al-Hattab, MD
Facility:
Name:
Mayo Clinic Health System-Franciscan Healthcare
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Scott H. Okuno, MD
Start date:
November 16, 2024
Completion date:
December 16, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06630104
https://www.mayo.edu/research/clinical-trials
