RECRUITING

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

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Conditions

Recurrent Multiple MyelomaRefractory Multiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-23
Study Completion:2031-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06940297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * 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)
  3. * Ciltacabtagene autoleucel (Carvykti) available for patient
  4. * Measurable disease
  5. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  6. * Life expectancy ≥ 12 weeks
  7. * Hemoglobin ≥ 8.0 g/dL (obtained ≤ 14 days prior to registration)
  8. * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (obtained ≤ 14 days prior to registration)
  9. * Platelet count ≥ 50,000/mm\^3 (obtained ≤ 14 days prior to registration)
  10. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)
  11. * Note: Patients with Gilbert's syndrome must have a total bilirubin of ≤ 3 x ULN (obtained ≤ 14 days prior to registration)
  12. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN (obtained ≤ 14 days prior to registration)
  13. * Alkaline phosphatase ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration)
  14. * Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)
  15. * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
  16. * Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  17. * 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
  18. * Provide written informed consent
  19. * Willingness to provide mandatory blood and bone marrow specimens for correlative research
  20. * Willingness to provide mandatory bone marrow cores and/or tissue specimens for correlative research
  21. * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  1. * Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis
  2. * Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.
  3. * EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 1 month since completion of prior treatment
  4. * Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
  5. * Pregnant persons
  6. * Nursing persons
  7. * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
  8. * Major surgery ≤ 28 days prior to registration
  9. * 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
  10. * Immunocompromised patients and patients known to be HIV positive.
  11. * 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
  12. * Evidence of cardiovascular disease risk, as defined by any of the following:
  13. * 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
  14. * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
  15. * Class III or IV heart failure as defined by the New York Heart Association functional classification system
  16. * Uncontrolled hypertension
  17. * History of life-threatening ventricular arrhythmias
  18. * QTC interval \[electrocardiogram (ECG)\] ≥ 450 msec
  19. * Uncontrolled intercurrent illness including, but not limited to:
  20. * Ongoing or active infection
  21. * Any medical condition that would make participation unduly hazardous
  22. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  23. * Live vaccine ≤ 6 weeks prior to registration
  24. * Has taken a strong inhibitor or inducer of CYP3A4/5, including grapefruit, St. John's Wort or related products ≤ 14 days prior to registration.
  25. * 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
  26. * Known hypersensitivity or allergy to dasatinib or quercetin
  27. * Patients on therapeutic doses of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc).
  28. * On antiplatelet agents (e.g. full dose aspirin, clopidogrel etc.)
  29. * NOTE: Baby aspirin, if necessary for cardioprotection, will be allowed
  30. * On quinolone antibiotic therapy for treatment or for prevention of infections products ≤10 days prior to registration

Contacts and Locations

Study Contact

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

Principal Investigator

Yi Lin, MD, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Yi Lin, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2031-08-15

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2031-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma