Lymphoproliferative DisorderNCT06630104
Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
A study testing Biospecimen Collection, Bone Marrow Aspiration and Electronic Health Record Review in people with Lymphoproliferative Disorder and Multiple Myeloma, run by Mayo Clinic at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoproliferative Disorder, Multiple Myeloma
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Nov 2024to 16 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ineligible for CAR-T therapy
- Patients diagnosed with myeloid neoplasm before CAR-T therapy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Mina S. Hanna, MD
- Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Eyad S. Al-Hattab, MD
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Talha Badar, MD
- Recruiting
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Scott H. Okuno, MD
- Recruiting
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Amrit B. Singh, MBBS
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Mithun V. Shah, MD, PhD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cecilia Y. Arana Yi, MD
About this study
Official title: MC230818 Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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 on research basis.
SECONDARY OBJECTIVE:
- Characterize the baseline transcriptomic signature associated with non-clonal and clonal cytopenia following CAR-T therapy on research basis.
OUTLINE:
Patients undergo bone marrow aspiration and hair, saliva, buccal swab, or skin 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 CFU on day 90.
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.
- Conditions
- Lymphoproliferative Disorder, Multiple Myeloma
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Electronic Health Record Review, Follow-Up, Genetic Counseling
- Medical subject headings
- Lymphoproliferative Disorders, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo hair, buccal, and saliva sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Electronic Health Record ReviewOther
Ancillary studies
Follow-UpProcedure or surgery
Also called Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up
Undergo CFU
Genetic CounselingOther
Receive genetic counselor consultation
Genetic TestingOther
Also called Genetic Analysis, Genetic Examination, Genetic Test
Undergo sequencing analysis
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (bone marrow aspiration, CFU) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Other: Electronic Health Record Review; Procedure: Follow-Up; Other: Genetic Counseling; Other: Genetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogenic and likely pathogenic germline and somatic variants associated with increased risk
The count and percentage of patients with the presence of somatic or germline variants will be reported. The number, type, and function of somatic variants will also be reported.
Measured: At baseline
Unexplained cytopenia
Unexplained cytopenia will be defined per World Health Organization (WHO)-5 as a combination of any of the following: hemoglobin < 12 g/dL in females, hemoglobin < 13 g/dL in males, absolute neutrophil count < 1.8 x 10^9/L and platelets < 150 x 10^9/L. Logistic regression will be used to identify the presence or absence of baseline germline and somatic mutations associated with unexplained cytopenia. An odds ratio and 95% confidence interval will be reported.
Measured: At day 90
Secondary outcomes (1)
Development of myeloid neoplasm post-cytotoxic therapies (MN-pCT)
Assessed as development of MN-pCT at any time following CAR-T infusion. MN-pCT is defined per The World Health Organization- Five Well-Being Index (WHO-5). The count and percentage of patients with the presence of somatic or germline variants will be reported. The number, type, and function of somatic variants will also be reported.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start22 Nov 2024
- Primary completion16 Dec 2029 (estimated)
- Study completion16 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mithun V. Shah, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630104
- Sponsor's protocol ID
- MC230818
- Other IDs
- 24-005734
- Status last verified
- Sep 2026
- First submitted
- 3 Oct 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC230818 Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy
- ClinicalTrials.gov ID
- NCT06630104
- Acronym / sponsor ID
- MC230818
- Conditions
- Lymphoproliferative Disorder, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 16 Dec 2029 (estimated)
- Study completion
- 16 Dec 2031 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 on research basis.
SECONDARY OBJECTIVE:
- Characterize the baseline transcriptomic signature associated with non-clonal and clonal cytopenia following CAR-T therapy on research basis.
OUTLINE:
Patients undergo bone marrow aspiration and hair, saliva, buccal swab, or skin 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 CFU on day 90.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (bone marrow aspiration, CFU) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Other: Electronic Health Record Review, Procedure: Follow-Up, Other: Genetic Counseling, Other: Genetic TestingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Ineligible for CAR-T therapy
- Patients diagnosed with myeloid neoplasm before CAR-T therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo hair, buccal, and saliva sample collection | Procedure or surgery | Supportive care (bone marrow aspiration, CFU) |
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | Supportive care (bone marrow aspiration, CFU) |
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (bone marrow aspiration, CFU) |
| Follow-UpAlso: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow UpUndergo CFU | Procedure or surgery | Supportive care (bone marrow aspiration, CFU) |
| Genetic CounselingReceive genetic counselor consultation | Other | Supportive care (bone marrow aspiration, CFU) |
| Genetic TestingAlso: Genetic Analysis, Genetic Examination, Genetic TestUndergo sequencing analysis | Other | Supportive care (bone marrow aspiration, CFU) |
Primary outcome
Pathogenic and likely pathogenic germline and somatic variants associated with increased risk
Time frame: At baseline
The count and percentage of patients with the presence of somatic or germline variants will be reported. The number, type, and function of somatic variants will also be reported.
Unexplained cytopenia
Time frame: At day 90
Unexplained cytopenia will be defined per World Health Organization (WHO)-5 as a combination of any of the following: hemoglobin < 12 g/dL in females, hemoglobin < 13 g/dL in males, absolute neutrophil count < 1.8 x 10^9/L and platelets < 150 x 10^9/L. Logistic regression will be used to identify the presence or absence of baseline germline and somatic mutations associated with unexplained cytopenia. An odds ratio and 95% confidence interval will be reported.
1 secondary outcome
Development of myeloid neoplasm post-cytotoxic therapies (MN-pCT)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mithun V. Shah, MD principal investigator
Mayo Clinic in Rochester
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Bone Marrow Aspiration and Electronic Health Record Review in people with Lymphoproliferative Disorder and Multiple Myeloma, run by Mayo Clinic at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogenic and likely pathogenic germline and somatic variants associated with increased risk (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.