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Extramedullary Disease in Multiple MyelomaPhase 2NCT06627751

Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease

A Phase 2 study testing Mezigdomide, Carfilzomib and Dexamethasone in people with Extramedullary Disease in Multiple Myeloma and Recurrent Multiple Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mezigdomide, Carfilzomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
1 May 2025to 1 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years of age
  • 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
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  • 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

Who cannot join

  • Participant has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥ grade 3 rash during prior thalidomide, lenalidomide, or pomalidomide therapy), carfilzomib or dexamethasone, any cereblon E3 ligase modulators (CELMoD) agents, or the excipients contained in the formulations, or participant has any contraindications per local prescribing information
  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ASK RPCI contact

8772757724

askroswell@roswellpark.org

United States1 site, 1 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Ask RPCI, 800-767-9355, ASKRPCI@roswellpark.org

    Jens Hillengass

    Recruiting

Other trials in United States

About this study

Official title: Phase II Clinical Trial of Mezigdomide/Carfilzomib/Dexamethasone (MeziKD) in Patients With Relapsed or Refractory Multiple Myeloma (MM) With Extramedullary Disease (EMD)

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.

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MezigdomideBiological

    Also called BMS 986348, CC-92480

    Given PO

  • CarfilzomibDrug

    Also called CFZ

    Given IV

  • DexamethasoneDrug

    Also called Adexone, Baycadron, Cortidexason, Decadron

    Given PO

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • Positron Emission TomographyProcedure or surgery

    Also called PET, PET scan

    Undergo PET/CT

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan

    Undergo PET/CT

  • Computed Tomography Assisted BiopsyProcedure or surgery

    Also called CT Assisted Biopsy

    Undergo CT guided tumor Biopsy

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration biopsy

  • Bone Marrow BiopsyProcedure or surgery

    Undergo bone marrow biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood and saliva sample collection

Study groups in NCT06627751
Study groupRoleWhat they receive
Treatment - MeziKDExperimentalPatients 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,
Receives: Biological: Mezigdomide; Drug: Carfilzomib; Drug: Dexamethasone; Procedure: Echocardiography; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Computed Tomography Assisted Biopsy; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Will be assessed in patients with serologically measurable disease. Will be defined as the percentage of patients with an objective response of partial response (PWR) or better by International Myeloma Working Group criteria on 2 consecutive evaluations among the eligible patients who began protocol treatment. Will be evaluated using a one-sided Binomial test and a 90% credible region for the overall response rate will be constructed using Jeffrey's prior method

    Measured: At the end of cycle 6 (each cycle is 28 days).

  2. Clinical benefit rate

    Will be assessed in patients with non- or oligo-secretory disease. Clinical benefit rate is the percentage of patients who remain progression-free and on protocol treatment for at least 6 months among the eligible patients who began protocol treatment. A 90% binomial credible region will be constructed for the clinical benefit rate using Jeffrey's prior method.

    Measured: At the end of cycle 6 (each cycle is 28 days)

Secondary outcomes (5)

  1. Incidence of Adverse Events (AEs)

    As per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0: type, frequency, seriousness, severity and relationship of AEs to mezigdomide and carfilzomib/dexamethasone. For each patient cohort, the AEs reported will be graded and an attribution assigned using CTCAE v5.0. For each patient, the maximum grade of each AE will be determined and the frequency of each AE by max grade will be tabulated for each cohort.

    Measured: Up to 30 days after last dose of study drug

  2. Duration of response

    For those with and without serologically measurable disease, the DOR will be estimated by Kaplan-Meier method. Estimates of the median will be obtained with 90% confidence intervals

    Measured: From the first documentation of response (≥ PR) to the first documentation of progressive disease or death, assessed up to 3 years

  3. Progression Free survival

    At screening, after 3 cycles of treatment (or progression, whichever occurs first), after 6 cycles of treatment, and then every 6 months for 3 years or until progression, start of a new therapy, or death (whichever occurs first)

    Measured: Time from first dose of mezigdomide to disease progression or death from any cause, whichever occurs first, assessed up to 3 years

  4. Overall Survival

    At screening, after 3 cycles of treatment (or progression, whichever occurs first), after 6 cycles of treatment, and then every 6 months for 3 years or until progression, start of a new therapy, or death (whichever occurs first)

    Measured: Time from first dose of mezigdomide to death from any cause, assessed up to 3 years

  5. Imaging Response

    Will be assessed in those without serologically measurable disease using positron emission tomography/computed tomography and magnetic resonance imaging. Will be assessed using Response Evaluation Criteria in Solid Tumors v1.1 and Deauville criteria.

    Measured: At screening, after 3 cycles of treatment (or progression, whichever occurs first), after 6 cycles of treatment, and then every 6 months for 3 years or until progression, start of a new therapy, or death (whichever occurs first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start1 May 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06627751
Sponsor's protocol ID
I-3576824
Status last verified
Aug 2026
First submitted
2 Oct 2024
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mezigdomide, Carfilzomib and Dexamethasone in people with Extramedullary Disease in Multiple Myeloma and Recurrent Multiple Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ASK RPCI (8772757724, askroswell@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: At the end of cycle 6 (each cycle is 28 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06627751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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