Phase II Clinical Trial of Mezigdomide/Carfilzomib/Dexamethasone (MeziKD) in Patients With Relapsed or Refractory Multiple Myeloma (MM) With Extramedullary Disease (EMD)
Roswell Park Cancer Institute
Summary
This phase II trial studies how well mezigdomide/carfilzomib/dexamethasone (MeziKD) works in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and have tumors from myeloma cells outside the bone marrow in the soft tissues or organs of the body (extramedullary disease \[EMD\]). Mezigdomide blocks important processes in myeloma cells and may lead to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a type of corticosteroid and is used to kill myeloma cells. It is used with other drugs to treat multiple myeloma. Giving MeziKD may kill more cancer cells in patients with relapsed/refractory multiple myeloma (RRMM) with EMD.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years of age * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * RRMM patients with one or more prior lines of therapy with at least one ES or PS lesion that is accessible to a biopsy. Accessibility will be assessed by the MM tumor board * Measurable disease meeting at least one of the following: * Serum M-protein ≥1 g/dL * Urine M-protein ≥200 mg/24 h * Serum FLC assay: involved FLC level ≥10 mg/dL provided serum FLC ratio is abnormal * Up to 10 patients without measurable disease can be enrolled but screening imaging and/or…
Interventions
- BiologicalMezigdomide
Given PO
- DrugCarfilzomib
Given IV
- DrugDexamethasone
Given PO
- ProcedureEchocardiography
Undergo ECHO
- ProcedurePositron Emission Tomography
Undergo PET/CT
- ProcedureComputed Tomography
Undergo PET/CT
- ProcedureComputed Tomography Assisted Biopsy
Undergo CT guided tumor Biopsy
Location
- Roswell Park Cancer InstituteBuffalo, New York