Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
NCT ID: NCT06627751
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2025-05-01
2030-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
NCT01903811
Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
NCT01812720
Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
NCT06050512
Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT01816971
A Phase 2, Single Arm Multicenter, Study Testing Mezigdomide, Carfilzomib, and Dexamethasone (480Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT07348393
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment - MeziKD
Patients receive mezigdomide PO QD on days 1-21 of each cycle, carfilzomib IV over 30 minutes on days 1, 8, and 15 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles of study treatment, patients showing a response to therapy may continue the treatment regimen as part of standard of care per physician's discretion. Additionally, patients undergo ECHO, PET/CT, MRI, CT guided tumor biopsy, bone marrow aspiration and biopsy, and blood and saliva sample collection throughout the study,
Mezigdomide
Given PO
Carfilzomib
Given IV
Dexamethasone
Given PO
Echocardiography
Undergo ECHO
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Computed Tomography Assisted Biopsy
Undergo CT guided tumor Biopsy
Bone Marrow Aspiration
Undergo bone marrow aspiration biopsy
Bone Marrow Biopsy
Undergo bone marrow biopsy
Biospecimen Collection
Undergo blood and saliva sample collection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mezigdomide
Given PO
Carfilzomib
Given IV
Dexamethasone
Given PO
Echocardiography
Undergo ECHO
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Computed Tomography Assisted Biopsy
Undergo CT guided tumor Biopsy
Bone Marrow Aspiration
Undergo bone marrow aspiration biopsy
Bone Marrow Biopsy
Undergo bone marrow biopsy
Biospecimen Collection
Undergo blood and saliva sample collection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* RRMM patients with one or more prior lines of therapy with at least one ES or PS lesion that is accessible to a biopsy. Accessibility will be assessed by the MM tumor board
* Measurable disease meeting at least one of the following:
* Serum M-protein ≥1 g/dL
* Urine M-protein ≥200 mg/24 h
* Serum FLC assay: involved FLC level ≥10 mg/dL provided serum FLC ratio is abnormal
* Up to 10 patients without measurable disease can be enrolled but screening imaging and/or bone marrow biopsy have to confirm RRMM. Follow-up response assessment will be performed with imaging using RECIST 1.1 and Deauville Criteria and bone marrow biopsies
* Absolute neutrophil count: ≥ 1 x 10\^9/L
* Platelets: ≥ 75 x 10\^9/L
* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 x ULN
* Renal function: Estimated creatinine clearance ≥ 30 mL/min (Cockroft-Gault)
* Adequate cardiac pump function with a left ventricular ejection fraction of ≥ 40%
* Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for at least 28 days after the last dose of mezigdomide or 6 months after the last dose of carfilzomib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Male patients (non-vasectomized) must agree to use contraception during the treatment period and for at least 28 days after the last dose of mezigdomide or 3 months after the last dose of carfilzomib and refrain from donating sperm during this period
* Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
* Administration of strong CYP3A modulators or proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study intervention
* Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
* Patient has evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
* Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participation in this study
* Known active infection requiring parenteral or oral anti-infective treatment within the past 14 days
* Participant has a history of prior malignancy other than MM, except if the participant has been free of disease for ≥ 3 years or the participant had 1 of the following noninvasive malignancies treated with curative intent without known recurrence:
* Basal or squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix or breast
* Stage 1 bladder cancer
* Incidental histological findings of localized prostate cancer such as tumor stage 1a or 1b (T1a or T1b) using the tumor, nodes, and metastasis (TNM) classification of malignant tumors OR prostate cancer that has been treated with curative intent
* Other ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to patient registration
* Pregnant or breast-feeding females
* Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation
* Known active HIV or hepatitis B or C viral infection
* Known history of HIV infection
* Systemic amyloidosis or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes)
* Prior peripheral stem cell transplant within 12 weeks of study enrollment
* Radiotherapy within 14 days prior to cycle 1 day 1. However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
* Known intolerance to steroid therapy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Carfilzomib-refractory in the most recent line of therapy
* Prior treatment with mezigdomide
* Contraindication against conscious sedation
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roswell Park Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jens Hillengass, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I-3576824
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.