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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
Patients need to have measurable disease defined by specific criteria including serum myeloma (M)-protein, urine M-protein, involved free light chain level, measurable plasmacytoma(s) verified by imaging or biopsy, and bone marrow biopsy demonstrating ≥30% infiltration of clonal plasma cells
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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 below
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I have multiple myeloma and have undergone 3 or more treatments.
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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.
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I am 18 years old or older.
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I can care for myself but may not be able to do heavy physical work, or I am mostly bedridden due to bone pain.
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My blood, liver, kidney, and heart are functioning well.
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I am following the required birth control guidelines due to my potential to conceive.
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I am a male and will use contraception to prevent pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Pomalidomide
2011
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,908 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,136 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

Belantamab Mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05556798 — Phase 1
Multiple Myeloma Research Study Groups: Belantamab Mafodotin and Nirogacestat
Multiple Myeloma Clinical Trial 2023: Belantamab Mafodotin Highlights & Side Effects. Trial Name: NCT05556798 — Phase 1
Belantamab Mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556798 — Phase 1

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
~20 spots leftby Oct 2026