RecruitingPhase 2NCT06627751

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)


Sponsor

Roswell Park Cancer Institute

Enrollment

28 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a three-drug combination — mezigdomide, carfilzomib, and dexamethasone — in patients with relapsed or refractory multiple myeloma (blood cancer that has returned or stopped responding to prior treatment) that has spread outside the bone marrow (called extramedullary disease), which is particularly hard to treat. **You may be eligible if...** - You are 18 or older - You have multiple myeloma that has returned or stopped responding after at least one prior treatment - Your myeloma has spread outside the bone marrow (extramedullary lesions) - Your disease shows measurable markers in blood or urine - You are in reasonable physical condition (ECOG ≤ 2) **You may NOT be eligible if...** - Your blood counts or organ function are below required thresholds - You have had prior treatment with mezigdomide - You have significant cardiovascular or other health conditions that make this regimen unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREBiospecimen Collection

Undergo blood and saliva sample collection


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT06627751


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