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Marizomib + Dexamethasone + Pomalidomide for Multiple Myeloma
Study Summary
This trial is testing whether an experimental drug is safe and effective when used with other drugs to treat cancer of the plasma cells.
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 2023 Phase 3 trial • 749 Patients • NCT03345095Trial Design
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Who is running the clinical trial?
Media Library
- I do not have amyloidosis or plasma cell leukemia.I have an active hepatitis B infection.I have heart problems that are not well-managed.I can take daily aspirin, or an alternative if allergic.I developed a peeling rash from thalidomide or similar drugs.I haven't had major surgery or radiation therapy in the last 4 weeks.I had a stem cell transplant and am experiencing significant symptoms from graft-versus-host disease.My multiple myeloma shows up on tests.I have not had certain treatments within a specific time before starting this therapy.I have no lasting side effects from past treatments above mild.I haven't taken strong medication or St. John's wort in the last 14 days.I have severe nerve pain or numbness.I have CNS involvement and my condition worsened after treatment with an IMiD and a proteasome inhibitor.I take more than 10 mg/day of corticosteroids, not including inhalers, for my multiple myeloma.You have had a serious skin reaction or severe allergic reaction to IMiD's® in the past.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have been diagnosed with multiple myeloma and need treatment now.My multiple myeloma has spread to my brain or spinal cord.I have a GI condition or had a procedure that affects my ability to absorb pills.I am following the POMALYST REMS® program's testing schedule.I have HIV or active hepatitis C.I have been diagnosed with POEMS syndrome.I have not needed treatment for an infection in the last 7 days.I cannot tolerate blood clot prevention treatments.I have been treated with marizomib and did not respond to pomalidomide or its combinations.I haven't had or been treated for another cancer in the last 3 years.You are allergic to thalidomide, lenalidomide, or any other drugs used in this study.I have RRMM, treated with at least two therapies including lenalidomide and a proteasome inhibitor, and my condition worsened within 60 days after the last treatment.Your recent lab test results need to be within certain ranges.
- Group 1: Marizomib plus pomalidomide and 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 are the desired outcomes of this clinical investigation?
"As per Bristol-Myers Squibb, the primary outcome of this trial will be gauged over a five year span from enrolment to either documented progression or death. This assessment is titled Maximum Tolerated Dose (MTD) Safety Run-In and secondary outcomes such as Progression Free Survival (PFS), Time To Response(TTR) and Duration Of Response (DOR) will also be evaluated using IMWG's updated response criteria developed in 2011 by Rajkumar."
How many volunteers are being incorporated into this research endeavor?
"This experiment is not presently accepting patients. Originally posted on March 1st 2023, the most recent edition was made July 14th 2022. For those in search of other clinical trials, there are currently 1816 studies recruiting for multiple myeloma and 571 Marizomib experiments with open enrollment."
For which medical conditions is Marizomib the preferred treatment?
"Marizomib has the potential to alleviate symptoms of ophthalmia, sympathetic eye disorders, and branch retinal vein occlusions."
Are there any current opportunities for individuals to become participants in this clinical trial?
"According to the data present on clinicaltrials.gov, this trial is no longer recruiting participants as it was last edited in July of 2022 and originally posted in March of 2023. Nevertheless, there are 2387 other medical studies that are currently seeking patients for their trials."
What other research has been conducted concerning Marizomib?
"Currently, there are 571 clinical trials observing the potential of Marizomib with 145 in Phase 3. Most studies for this drug occur in Mishawaka, Indiana however it is being assessed at 18,862 locations worldwide."
What precautions should be taken when using Marizomib therapeutically?
"Our team has judged marizomib to possess a safety rating of 2, as the Phase 2 trial does not provide evidence for efficacy yet includes some data on its security."
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