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
Qualifiers
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
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Ciltacabtagene Autoleucel
- Computed Tomography
- Cyclophosphamide
- Dasatinib
- Fludarabine
- Positron Emission Tomography
- Quercetin
Treatment groups
Sponsors and collaborators
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator