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New treatment option for Extramedullary Disease in Multiple Myeloma
Official title Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease
ClinicalTrials.gov ID: NCT06627751
What this study is testing
What is Mezigdomide?
Mezigdomide is an investigational medicine, being studied as a potential treatment for extramedullary disease in multiple myeloma.
Also referred to as BMS 986348, CC-92480.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable disease meeting at least one of the following:
- Serum M-protein ≥1 g/dL
You likely can't join if
- Participant has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥ grade 3 rash during prior...
- Administration of strong CYP3A modulators or proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within...
- 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...
- Known active infection requiring parenteral or oral anti-infective treatment within the past 14 days
See the full eligibility criteria
Who can 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
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.