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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Undergo tumor biopsy
Undergo blood sample collection
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Given IV
Undergo CT scan
Given IV
Given PO
Given IV
Undergo PET scan
Given PO
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGMinimal 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.
Time frame: At 3 months
Overall response rate (ORR)
Assessed by the number of patients who achieve any response (partial response or better) to therapy.
Time frame: Up to 2 years
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).
Time frame: Up to 2 years
Progression free survival (PFS)
Defined as the time from study registration to the time of documented disease progression or death due to any cause.
Time frame: Up to 2 years
Duration of response
Defined as the time from first documented response to the time of progression and/or death due to any cause.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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