Actively Recruiting
Phase II Trial of Mezigdomide, Carfilzomib, and Dexamethasone for Relapsed or Refractory Multiple Myeloma With Extramedullary Disease
Led by Roswell Park Cancer Institute · Updated on 2026-01-12
28
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment of mezigdomide, carfilzomib, and dexamethasone (MeziKD) for adults with multiple myeloma that has returned after treatment or does not respond to treatment, especially in those with tumors outside the bone marrow (extramedullary disease). Mezigdomide works by blocking processes in myeloma cells and may activate immune cells, while carfilzomib blocks enzymes needed for cancer growth. Dexamethasone, a corticosteroid, is also used to kill myeloma cells alongside these drugs. Participants receive mezigdomide orally once daily on days 1 to 21 of each 28-day cycle. Carfilzomib is given intravenously over 30 minutes on days 1, 8, and 15, and dexamethasone is taken orally on days 1, 8, 15, and 22 of each cycle. Treatment continues up to six cycles unless the disease worsens or side effects become unacceptable. Patients responding after six cycles may continue treatment as part of their standard care. Throughout the study, participants undergo various imaging tests like echocardiography, PET/CT, MRI, CT-guided tumor biopsy, bone marrow aspiration and biopsy, and blood and saliva sample collection. During the study, researchers assess overall response and clinical benefit rates after six treatment cycles. They also monitor side effects for up to 30 days after the last dose and evaluate how long responses last, progression-free survival, overall survival, and imaging responses for up to three years. These evaluations include regular scans and biopsies to understand treatment effects and disease status. Participants are carefully monitored to ensure safety and treatment adherence during the trial period.
CONDITIONS
Brief 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 prior therapy and at least one accessible extramedullary or paraskeletal lesion for biopsy
- Measurable disease by serum M-protein, urine M-protein, or serum free light chain assay, with some exceptions
- Absolute neutrophil count of at least 1 x 10^9/L
- Platelets of at least 75 x 10^9/L
- Total bilirubin at or below 1.5 times the upper limit of normal
- AST and ALT levels at or below 3 times the upper limit of normal
- Estimated creatinine clearance of at least 30 mL/min
- Left ventricular ejection fraction of 40% or higher
- Women of child-bearing potential must use effective contraception before and after treatment
- Male patients must use contraception during treatment and for a period after
- Ability to understand the investigational nature and provide written informed consent
You will not qualify if you...
- History of severe allergic reaction or hypersensitivity to study drugs or related agents
- Use of strong CYP3A modulators or proton-pump inhibitors within 2 weeks before starting treatment
- Inability or refusal to undergo blood clot prevention treatment as required
- Evidence of bleeding or platelet transfusion refractoriness
- Medical conditions that pose excessive risk or interfere with study participation
- Active infections requiring treatment within 14 days prior to study
- History of other cancers unless disease-free for 3 years or certain early-stage cancers treated curatively
- Concurrent anti-myeloma therapies except stable low-dose corticosteroids or bisphosphonates
- Pregnancy or breastfeeding
- Serious psychiatric illness, active alcoholism, or drug addiction affecting follow-up
- Known active HIV or hepatitis B or C infection
- Systemic amyloidosis or POEMS syndrome
- Recent stem cell transplant or radiotherapy within specified time frames
- Intolerance to steroid therapy
- Uncontrolled illnesses such as heart failure or severe arrhythmia
- Refractory to carfilzomib in the most recent therapy line
- Prior treatment with mezigdomide
- Contraindications to conscious sedation
- Inability or unwillingness to follow protocol requirements
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive mezigdomide orally daily on days 1-21, carfilzomib intravenously on days 1, 8, and 15, and dexamethasone orally on days 1, 8, 15, and 22 of each 28-day cycle. This treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
3 visits per cycle for carfilzomib infusion and additional visits for oral medications
Duration - Up to 3 years
Participants who respond to therapy may continue treatment as part of standard care. Imaging assessments and biopsies occur throughout the study, with follow-up assessments every 6 months for up to 3 years or until progression, new therapy, or death.
Imaging and assessments at screening, after 3 and 6 cycles, then every 6 months
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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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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