Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Mu
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
| Condition(s) | Extramedullary Disease in Multiple Myeloma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 cortico |
| Who can participate | 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 bone marrow biopsy have to confirm RRMM. Follow-up response assessment will be performed with imaging using RECIST 1.1 and Deauville Criteria and bone marrow biopsies * Absolute neutrophil count: ≥ 1 x 10\^9/L |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Roswell Park Cancer Institute |
| Locations | Buffalo, New York, United States |
| Start date | 2025-05-01 |
| NCT ID | NCT06627751 |
| Official listing | https://clinicaltrials.gov/study/NCT06627751 |