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Triple Drug Therapy for Multiple Myeloma
Study Summary
This trial is testing the combination of leflunomide, pomalidomide, and dexamethasone to treat patients with multiple myeloma that has returned or is resistant to treatment.
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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Who is running the clinical trial?
Media Library
- I have been diagnosed with rheumatoid arthritis.I have been diagnosed with multiple myeloma and it can be measured.You have tested positive for hepatitis A, B, or C.I am not using other myeloma treatments besides leflunomide, pomalidomide, and dexamethasone.I have not had a serious infection needing treatment in the last 2 weeks.I have had a transplant from a donor.My condition did not improve after treatment with a proteasome inhibitor and an immunomodulatory drug, and transplant is not currently recommended for me.You are expected to live for more than 3 months.Your white blood cell count is at least 1.0 x 10^9/L.Your alkaline phosphatase levels should not be more than 5 times the upper limit of normal.I have been treated for skin cancer.I am capable of having children and have not been surgically sterilized.I am currently receiving or planning to receive growth factor or transfusion support.Your bilirubin levels are normal unless you have Gilbert's disease.I am HIV positive.Your AST level is not more than 3.5 times the upper limit of normal.Your kidneys are working well enough, as shown by a urine test done within the last 30 days.Your blood test shows high levels of involved light chain and an abnormal ratio of two specific proteins.Your hemoglobin level is at least 8.0 grams per deciliter.You had a serious allergic reaction to thalidomide, lenalidomide, pomalidomide, cholestyramine, or dexamethasone in the past.I have early-stage cervical cancer.Your alanine aminotransferase (ALT) level is not more than 3.5 times the upper limit of normal.You have more than 200 milligrams of protein in your urine over a 24-hour period.My condition worsened within 60 days of taking pomalidomide alone or with other treatments.You have high levels of M-protein in your blood.I am a woman who can have children and my pregnancy test is negative.My prostate cancer is low grade and my PSA levels are stable.I have been treated with leflunomide before.I am not pregnant or breastfeeding.I am able to get out of my bed or chair and move around.I haven't had cancer other than blood cancer in the last 3 years.My IgA myeloma is measured by IgA levels, which are 0.50 g/dL or higher.I have tested positive for tuberculosis.I have recovered from side effects of cancer treatment, except for hair loss.I had a non-invasive breast cancer that was treated successfully.Your platelet count is at least 75 billion per liter within the last 30 days before starting the treatment.
- Group 1: Treatment (leflunomide, pomalidomide, dexamethasone)
- 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 conditions is leflunomide typically employed to address?
"Leflunomide can be prescribed to ease ophthalmic and sympathetic conditions, including branch retinal vein occlusion, macular edema, and assorted eye-related maladies."
Are there still vacancies for participants in this experiment?
"Affirmative. Clinicaltrials.gov provides proof that this research is currently in the process of recruiting participants, with the initial posting having been made on November 27th 2020 and last updated on January 10th 2022. In total 29 people are needed to be enrolled at one medical site."
Have any other studies explored the efficacy of utilizing Leflunomide?
"To date, 583 medical trials are currently investigating the uses of leflunomide with 146 studies in its advanced phase 3. Most clinical research is conducted in Mishawaka, Indiana; nevertheless, there are 18799 locations across the globe conducting experiments involving this drug."
Does the Food and Drug Administration condone leflunomide?
"Taking into consideration that Leflunomide is in Phase 2 of its clinical trials, our team at Power have surmised a safety rating of 2 for the drug due to existing data on its security but no evidence yet supporting efficacy."
How many participants are engaged with this research endeavor?
"Confirmed. Clinicaltrials.gov displays that this medical trial, which was first announced on November 27th 2020, is still actively recruiting participants from one location with a target of 29 enrollees."
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