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Leflunomide for High-Risk Smoldering Multiple Myeloma
Study Summary
This trial looks at the effects of leflunomide in treating patients with high-risk smoldering multiple myeloma who are African-American or European-American. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 400 Patients • NCT01172639Trial Design
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- You have at least one small abnormal area (5 millimeters or larger) on your MRI scan.You do not have hepatitis A, B, or C infection.You have had allergic reactions to drugs similar to leflunomide and cholestyramine.My kidney function, measured by creatinine clearance, is adequate.I haven't had cancer other than lung cancer in the past 3 years.Your involved serum free light chain ratio is 100 or higher.My lung function tests show at least half the normal capacity.You are expected to live for more than 24 months.If you have at least two of the listed risk factors.I have been treated for skin cancer.I have early-stage cervical cancer.You have more than 20% of a certain type of cells in your bone marrow.I have been diagnosed with rheumatoid arthritis.I have had a transplant from a donor.I am HIV positive.I have one or more bone lesions detectable by scans.I am able to get out of my bed or chair and move around.I was diagnosed with high-risk smoldering multiple myeloma within the last 3 years.I am 18 years old or older.You do not have tuberculosis, as shown by a specific test called the T-Spot test.I have been successfully treated for a non-invasive breast cancer.My cancer has at least one known biomarker.Your blood calcium levels are too high, which is a sign of a health problem.My prostate cancer is low grade with a stable PSA level.Your hemoglobin level is either too low or too high.I have been treated with leflunomide before.My CRAB symptoms are not caused by my current illness.I am not using, nor plan to use, other experimental treatments or certain therapies during the study.Women who can have children must have a negative pregnancy test.Your AST and ALT levels should be less than 2 times the upper limit of normal.I haven't had any cancer treatment or steroids (except low-dose prednisone) in the last 2 weeks.My condition has caused damage to my organs.I have been diagnosed with high-risk smoldering multiple myeloma.I am a woman who can still have children.You have a high level of M-protein in your blood.Your body has enough infection-fighting white blood cells.I have received treatment for early-stage multiple myeloma.Your bilirubin levels in the blood are within normal range.Your bone marrow contains over 60% of a certain type of cells called plasma cells.My kidney function is low, with creatinine clearance below 30 mL/min or serum creatinine above 2 mg/dL.I have a liver condition.I am not pregnant or breastfeeding.The ratio of certain proteins in your blood is higher than normal.I have not had a serious infection needing treatment in the last 2 weeks.My platelet count is at least 50,000 and I haven't had a transfusion in 2 weeks.
- Group 1: Treatment (leflunomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other investigations have been conducted with respect to Leflunomide?
"The first study of leflunomide occurred in 2007 at University of Nebraska Medical Centre. To date, 43 trials have been completed and 15 are currently running; several of these being held out of Charlotte, North carolina."
What deleterious effects has Leflunomide been known to cause?
"Our team at Power has determined that leflunomide is moderately safe, scoring a 2 on the safety scale. This evaluation was based on its status as a Phase 2 trial, which implies some data points to its security but no evidence of efficacy yet."
What is the enrollment size of this investigation?
"To complete this clinical trial, 20 volunteers who meet the criteria must participate. Volunteers can join from Atrium Health University City/LCI-University in Charlotte and Wayne State University/Karmanos Cancer Institute in Detroit."
What conditions is Leflunomide regularly utilized to treat?
"Leflunomide is typically prescribed for atherogenesis, however it has also been proven to be beneficial in managing primary hypercholesterolemia, partial biliary obstruction and alleviating pruritus."
Is participation in this experiment still available?
"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical study, which was initially advertised on March 7th 2022, is currently recruiting. Approximately 20 individuals need to be recruited from 3 distinct healthcare facilities."
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