Is NCT06627751 recruiting in Buffalo, NY?

Yes, NCT06627751 is currently recruiting participants at its Buffalo, NY location. This extramedullary disease in multiple myeloma clinical trial is actively enrolling qualified participants.

Is participation in this Buffalo clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Extramedullary Disease in Multiple Myeloma Clinical Trial in Buffalo, NY

Q: How do I join the extramedullary disease in multiple myeloma clinical trial in Buffalo?

To join this clinical trial in Buffalo, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Extramedullary Disease in Multiple Myeloma Study in Buffalo

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.

Sponsor: Roswell Park Cancer Institute

Who Can Participate

Inclusion Criteria

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 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

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Buffalo?

Yes, this clinical trial (NCT06627751) has an active research site in Buffalo, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Extramedullary Disease in Multiple Myeloma Treatment Options in Buffalo, NY

If you're searching for extramedullary disease in multiple myeloma treatment options in Buffalo, NY, this clinical trial (NCT06627751) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Buffalo research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced extramedullary disease in multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all extramedullary disease in multiple myeloma clinical trials near you to find additional studies recruiting in your area.

Extramedullary Disease in Multiple Myeloma Clinical Trial in Buffalo, NY

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