Trials / Recruiting
RecruitingNCT06627751
Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
Phase II Clinical Trial of Mezigdomide/Carfilzomib/Dexamethasone (MeziKD) in Patients With Relapsed or Refractory Multiple Myeloma (MM) With Extramedullary Disease (EMD)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mezigdomide | Given PO |
| DRUG | Carfilzomib | Given IV |
| DRUG | Dexamethasone | Given PO |
| PROCEDURE | Echocardiography | Undergo ECHO |
| PROCEDURE | Positron Emission Tomography | Undergo PET/CT |
| PROCEDURE | Computed Tomography | Undergo PET/CT |
| PROCEDURE | Computed Tomography Assisted Biopsy | Undergo CT guided tumor Biopsy |
| PROCEDURE | Bone Marrow Aspiration | Undergo bone marrow aspiration biopsy |
| PROCEDURE | Bone Marrow Biopsy | Undergo bone marrow biopsy |
| PROCEDURE | Biospecimen Collection | Undergo blood and saliva sample collection |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2027-05-01
- Completion
- 2030-05-01
- First posted
- 2024-10-04
- Last updated
- 2026-01-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06627751. Inclusion in this directory is not an endorsement.