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Recurrent Multiple MyelomaPhase 2NCT06940297

Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Aspiration in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Bone Marrow Aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
18 Sep 2025to 15 Aug 2031
Phase
Phase 2
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
  • Relapsed or refractory multiple myeloma who has had at least 3 prior lines of therapies including a proteasome inhibitor, immunomodulatory drug (IMiD) and anti-CD38 monoclonal antibody (mAb)
  • Ciltacabtagene autoleucel (Carvykti) available for patient
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Life expectancy ≥ 12 weeks
  • Hemoglobin ≥ 8.0 g/dL (obtained ≤ 14 days prior to registration)
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  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (obtained ≤ 14 days prior to registration)
  • Platelet count ≥ 50,000/mm^3 (obtained ≤ 14 days prior to registration)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
  • Note: Patients with Gilbert's syndrome must have a total bilirubin of ≤ 3 x ULN (obtained ≤ 14 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN (obtained ≤ 14 days prior to registration)
  • Alkaline phosphatase ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration)
  • Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
  • Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 30 days after the last dose of study drug
  • Provide written informed consent
  • Willingness to provide mandatory blood and bone marrow specimens for correlative research
  • Willingness to provide mandatory bone marrow cores and/or tissue specimens for correlative research
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Who cannot join

  • Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis
  • Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.
  • EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 1 month since completion of prior treatment
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
  • Pregnant persons
  • Nursing persons
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  • Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
  • Major surgery ≤ 28 days prior to registration
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients and patients known to be HIV positive.
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, or those currently receiving antiretroviral therapy with good control of HIV, are eligible for this trial
  • Evidence of cardiovascular disease risk, as defined by any of the following:
  • Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system
  • Uncontrolled hypertension
  • History of life-threatening ventricular arrhythmias
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Any medical condition that would make participation unduly hazardous
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Live vaccine ≤ 6 weeks prior to registration
  • Has taken a strong inhibitor or inducer of CYP3A4/5, including grapefruit, St. John's Wort or related products ≤ 14 days prior to registration.
  • Note: If required, patients may receive a short course of strong inhibitors or inducers for treatment of symptoms, but dasatinib dose must be adjusted as indicated
  • Known hypersensitivity or allergy to dasatinib or quercetin
  • Patients on therapeutic doses of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc).
  • On antiplatelet agents (e.g. full dose aspirin, clopidogrel etc.)
  • NOTE: Baby aspirin, if necessary for cardioprotection, will be allowed
  • On quinolone antibiotic therapy for treatment or for prevention of infections products ≤10 days prior to registration

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Yi Lin, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Receiving CAR-T Therapy

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.

Being tested
Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Ciltacabtagene Autoleucel
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Ciltacabtagene AutoleucelBiological

    Also called Autologous Anti-B-cell maturation antigen (BCMA) CAR-T Cells JNJ-68284528, Autologous Bi-epitope BCMA-targeted CAR T-cells JNJ-68284528, Autologous Bi-epitope CAR T-cells JNJ-68284528, CARVYKTI

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518

    Given IV

  • DasatinibDrug

    Also called BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate

    Given PO

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • QuercetinDrug

    Also called 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one, 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-chromen-4-one, C.I. Natural Yellow 10

    Given PO

Study groups in NCT06940297
Study groupRoleWhat they receive
Treatment (Dasatinib, quercetin, chemotherapy, CAR-T)ExperimentalPatients receive dasatinib by mouth (PO) once a day (QD) and quercetin PO twice a day (BID) on days -7 and -6 and cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive CAR-T IV on day 0. Patients receive dasatinib PO QD and quercetin PO BID on days 28, 29, 58, 59, 88 and 89 in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET, tumor biopsy, bone marrow aspirate and biopsy and blood sample collection throughout the study.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Biological: Ciltacabtagene Autoleucel; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Dasatinib; Drug: Fludarabine; Procedure: Positron Emission Tomography; Drug: Quercetin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimal residual disease (MRD) negativity rate

    Defined as the number of patients who are able to achieve undetectable MRD based on bone marrow (BM) and positron emission tomography (PET) evaluations.

    Measured: At 3 months

Secondary outcomes (5)

  1. Overall response rate (ORR)

    Assessed by the number of patients who achieve any response (partial response or better) to therapy.

    Measured: Up to 2 years

  2. Depth of response

    Assessed by the number of patients who are able to achieve different levels of response, such as partial response (PR), very good partial response (VGPR), and complete response (CR), or stringent complete response (sCR).

    Measured: Up to 2 years

  3. Progression free survival (PFS)

    Defined as the time from study registration to the time of documented disease progression or death due to any cause.

    Measured: Up to 2 years

  4. Duration of response

    Defined as the time from first documented response to the time of progression and/or death due to any cause.

    Measured: Up to 2 years

  5. Incidence of adverse events (AEs)

    AEs will be summarized per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5, and where toxicities will be defined as adverse events that are deemed to be at least possibly treatment-related. The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized.

    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.

  1. First posted23 Apr 2025
  2. Study start18 Sep 2025
  3. Primary completion15 Aug 2031 (estimated)
  4. Study completion15 Aug 2031 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940297
Sponsor's protocol ID
MC240801
Other IDs
NCI-2025-02490, 24-002915, MC240801, P50CA186781
Status last verified
Aug 2026
First submitted
15 Apr 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Aspiration in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Mayo Clinic at 1 site 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 20 inclusion and 29 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Minimal residual disease (MRD) negativity rate (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940297.

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 26 Aug 2026.

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