About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Pregnant persons
Trial design
Single group
Treatments tested in this trial
Biopsy Procedure
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Ciltacabtagene Autoleucel
Biological/VaccineGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT scan
Cyclophosphamide
DrugGiven IV
Dasatinib
DrugGiven PO
Fludarabine
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Quercetin
DrugGiven PO
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall response rate (ORR)
Assessed by the number of patients who achieve any response (partial response or better) to therapy.
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).
Progression free survival (PFS)
Defined as the time from study registration to the time of documented disease progression or death due to any cause.
Duration of response
Defined as the time from first documented response to the time of progression and/or death due to any cause.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator