Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
NCT06627751 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-01-12
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
- Extramedullary Disease in Multiple Myeloma
- Recurrent Multiple Myeloma
- Refractory Multiple Myeloma
Interventions
- BIOLOGICAL
-
Given PO
- DRUG
-
Given IV
- DRUG
-
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
Sponsors & Collaborators
-
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Jens Hillengass, MD · Roswell Park Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2027-05-01
- Completion
- 2030-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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