Actively Recruiting
Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
Led by Roswell Park Cancer Institute · Updated on 2026-01-12
28
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Relapsed or refractory multiple myeloma patients with at least one accessible extramedullary or plasmacytoma lesion suitable for biopsy
- Measurable disease with serum M-protein 1 g/dL, or urine M-protein 200 mg/24 h, or involved serum free light chain level 10 mg/dL with abnormal ratio
- Up to 10 patients without measurable disease can enroll if RRMM is confirmed by imaging and/or bone marrow biopsy
- Absolute neutrophil count 1 x 10^9/L
- Platelet count 75 x 10^9/L
- Total bilirubin 1.5 times upper limit of normal
- AST/ALT 3 times upper limit of normal
- Estimated creatinine clearance 30 mL/min
- Left ventricular ejection fraction 40%
- Women of child-bearing potential must use adequate contraception during and after treatment as specified
- Male patients (non-vasectomized) must use contraception during and after treatment as specified
- Ability to understand the investigational nature and sign informed consent
You will not qualify if you...
- History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, carfilzomib, dexamethasone, cereblon E3 ligase modulators, or formulation excipients
- Use of strong CYP3A modulators or proton-pump inhibitors within 2 weeks before starting study treatment
- Inability or unwillingness to undergo required thromboembolism prophylaxis
- Evidence of mucosal or internal bleeding or platelet transfusion refractoriness
- Medical conditions that pose excessive risk or affect study participation
- Active infection requiring treatment within past 14 days
- History of prior malignancy except if disease-free for 3 years or certain noninvasive cancers treated curatively
- Ongoing anti-myeloma therapy except stable low-dose corticosteroids or bisphosphonates
- Pregnant or breastfeeding females
- Serious psychiatric illness, active alcoholism, or drug addiction
- Known active HIV or hepatitis B or C infection
- Systemic amyloidosis or POEMS syndrome
- Peripheral stem cell transplant within 12 weeks prior to enrollment
- Radiotherapy within 14 days before cycle 1 day 1, unless limited to 5% bone marrow
- Known intolerance to steroid therapy
- Uncontrolled serious illness including infections or heart conditions
- Carfilzomib-refractory in most recent therapy line
- Prior treatment with mezigdomide
- Contraindication to conscious sedation
- Unwilling or unable to follow protocol requirements
- Any condition making participant unsuitable for study drug per investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
A
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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