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Belantamab Mafodotin + Nirogacestat + Pomalidomide for Multiple Myeloma
Study Summary
This trial is testing the safety and efficacy of two drugs, belantamab mafodotin and nirogacestat, for people with relapsed or refractory 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.Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 4 weeks.I have an active liver or biliary disease.I have a cancer type other than multiple myeloma.I am at risk for heart disease.I am currently experiencing bleeding from an internal organ or mucosa.I have tested positive for hepatitis B.I am 18 years old or older.I have been treated with belantamab mafodotin before.I do not have any serious health or mental conditions that could affect my safety in the trial.I have a condition that affects how my body absorbs nutrients.I am not taking strong CYP1A2 inhibitors while on pomalidomide.I have had a stem cell transplant using my own cells or am not eligible for one.My cancer can be measured by blood tests, urine tests, imaging, or biopsy.I had a stem cell transplant less than 60 days ago if it was my own cells, or less than 100 days ago if it was from a donor.I can care for myself but may not be able to do heavy physical work, or I am mostly bedridden due to bone pain.I haven't taken any experimental drugs recently.I have multiple myeloma and have undergone 3 or more treatments.I haven't had any myeloma treatment or plasmapheresis in the last 2 weeks.I have an active kidney condition.My blood, liver, kidney, and heart are functioning well.I have previously received CAR T cell therapy.I have not had radiation therapy in the last 2 weeks.I am currently being treated for an infection.I have been diagnosed with AL amyloidosis.I haven't taken any monoclonal antibody treatments in the last 30 days.I have a disease affecting my cornea.I haven't taken strong or moderate CYP3A4 inhibitors or inducers in the last 14 days.You have had an allergic reaction to drugs similar to belantamab mafodotin.You have been diagnosed with HIV.You have tested positive for hepatitis C within the last 3 months.I am following the required birth control guidelines due to my potential to conceive.I am a male and will use contraception to prevent pregnancy.
- Group 1: Belantamab Mafodotin and Nirogacestat
- 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 FDA's official thoughts on Belantamab Mafodotin and Nirogacestat?
"Belantamab Mafodotin and Nirogacestat are still in the early stages of testing, so they receive a score of 1 for safety."
Are there any current openings for this clinical trial?
"Indeed, this clinical trial is still seeking patients. The listing on clinicaltrials.gov shows that the original posting was on October 4th, 2022 and there has been one update since then on October 5th, 20202."
How many study subjects are you working with in this research?
"The trial is still recruiting patients, as of the most recent update on clinicaltrials.gov from October 5th, 2022. This particular study was first posted on October 4th, 2020 and is looking for 30 individuals total from 7 different locations."
Is this clinical trial being conducted in more than one location within the city limits?
"This study can be undertaken at 7 different locations, which are situated in Harrison, Montvale and Commack amongst other places. To limit the amount of travel needed, patients should pick a location near to them."
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