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Monoclonal Antibodies
Belantamab Mafodotin + Nirogacestat + Pomalidomide for Multiple Myeloma
Phase 1
Recruiting
Led By Malin Hultcrantz, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with relapsed or refractory multiple myeloma treated with 3 or more prior lines of therapy as defined by the International Myeloma Working Group (IMWG) updated criteria
Female or male patients age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with multiple myeloma that hasn't improved or has returned after treatment. Participants must have measurable disease, may have had a stem cell transplant or be ineligible for one, and should not have major health issues that could affect safety. They need to agree to contraception use and follow specific drug safety programs.Check my eligibility
What is being tested?
Researchers are testing the combination of belantamab mafodotin, nirogacestat, and pomalidomide on patients with relapsed or refractory multiple myeloma. They aim to determine the safest doses and effectiveness in slowing down or stopping cancer growth.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision due to corneal changes, blood disorders such as low platelet counts leading to bleeding risks, fatigue, digestive issues including nausea and constipation, increased risk of infections due to immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple myeloma and have undergone 3 or more treatments.
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I am 18 years old or older.
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My cancer can be measured by blood tests, urine tests, imaging, or biopsy.
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I have had a stem cell transplant using my own cells or am not eligible for one.
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I have previously received CAR T cell therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Clinical Response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Belantamab Mafodotin and NirogacestatExperimental Treatment3 Interventions
There will be a 1:1 randomization betweennirogacestat 100 mg BID or 100 mg QD during the 4day run-in period prior to starting belantamab mafodotin on Cycle 1 Day 1 (days -4 to -1). The cycle length for Cycles 1-3 is 21 days (3 weeks). Treatment with nirogacestat will be 100 mg BID continuously during each cycle for all subjects. Belantamab mafodotin will be administered via IV infusion in an outpatient setting on Day 1 of Cycles 1-3 and nirogacestat 100mg BID will be administered continuously on Days 1-21 of each cycle. Treatment with belantamab mafodotin will be given at an initial dose of 1.0 mg/kg. The study will have a 3+3 dose escalation design for belantamab mafodotin. Belantamab mafodotin dose levels are 1.0 mg/kg, 1.4 mg/kg, and 1.9 mg/kg. Pomalidomide was added, 2 mg to the 1.4 mg/kg and 1.9 mg/kg dose cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab Mafodotin
2021
Completed Phase 2
~10
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,868 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,137 Patients Enrolled for Multiple Myeloma
Malin Hultcrantz, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
43 Total Patients Enrolled
2 Trials studying Multiple Myeloma
43 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Belantamab Mafodotin and Nirogacestat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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