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Triple Drug Regimen for Multiple Myeloma
Study Summary
This trial is testing idasanutlin, ixazomib citrate, and dexamethasone to see if they're effective in treating patients with multiple myeloma that has returned.
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.Trial Design
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Who is running the clinical trial?
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- I do not have any major health issues that would prevent me from joining the trial.I have moderate to severe nerve damage in my hands or feet, or mild with pain.I am HIV positive.I am not pregnant or breastfeeding.You have a certain amount of abnormal protein in your blood or urine.I have mild or no diarrhea and am not on antidiarrheal medication.I have been treated with ixazomib or was in a study for it.I have multiple myeloma with a specific genetic change and have undergone treatment.I am able to care for myself and perform daily activities.I do not have uncontrolled heart conditions or recent heart attacks.Your heart takes too long to recover after each beat, as shown in a special heart test.Your total bilirubin level should not be higher than 1.5 times the upper limit of the normal range.I need medication to prevent blood clots.Your white blood cell count is at least 1500 per cubic millimeter.My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.I am not undergoing treatment for any cancer except for skin, breast, or cervical pre-cancers.Women who can have babies need to have a negative pregnancy test within 7 days before joining the study.I have stopped taking all CYP2C8 related medications for at least 7 days.Your hemoglobin level is at least 8.0 grams per deciliter.Your AST and ALT levels in your blood are not more than 3 times the upper limit of normal.Your platelet count is at least 75,000 per cubic millimeter.I am willing to give bone marrow and blood samples for research.You have a current or suspected infection of hepatitis B or C.I haven't taken strong CYP3A4 medications in the last 14 days.I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.I have not had major surgery in the last 14 days.
- Group 1: Treatment (ixazomib citrate, idasanutlin, 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
Why was this clinical research created?
"The primary goal of this 28 day trial is to observe and document any adverse events that occur. These will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events. Additionally, researchers will keep track of the rate of complete and partial responses in order to better understand the efficacy of the treatment."
Are there any participating hospitals in Canada?
"A few of the 8 locations where this study is recruiting patients are Mayo Clinic in Rochester, Minnesota, City of Hope Comprehensive Cancer Center in Duarte, California, and Wayne State University/Karmanos Cancer Institute in Detroit, Michigan."
Are there any other drugs that have been trialed in a similar way to Pharmacological Study?
"Pharmacological Study was first trialed in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, a total of 1719 trials have been completed with 605 ongoing clinical trials. Many of these current studies are based out of Rochester, Minnesota."
What do doctors use Pharmacological Study to manage?
"Pharmacological Study is often used to treat ophthalmia, sympathetic. However, it has also been known to effectively manage conditions such as branch retinal vein occlusion, macular edema, and other issues with the eye."
Are patients currently being signed up for this clinical trial?
"According to the information available on clinicaltrials.gov, this particular study is no longer recruiting patients for participation. The trial was initially posted on December 30th, 2015 but was most recently updated on June 1st, 2022. Although this trial is not currently looking for new participants, there are 1433 other studies that are still recruiting patients."
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