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Monoclonal Antibodies
Belantamab Mafodotin for Multiple Myeloma
Phase 2
Recruiting
Led By Ricardo D Parrondo
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined in International Myeloma Working Group (IMWG) criteria
Has measurable disease with at least one of the following: Serum M-protein >= 0.5 g/dL, Urine M-protein >= 200 mg/24 h, Serum free light chain (FLC) assay: Involved FLC level >= 10 mg/dL and an abnormal serum free light chain ratio
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests different doses and schedules of belantamab mafodtin to treat multiple myeloma that has come back or doesn't respond to treatment. It may help reduce side effects and treat patients better.
Who is the study for?
Adults with multiple myeloma that's resistant to standard treatments, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. Participants must have adequate organ function and not be pregnant or planning to become pregnant. They should not have certain other medical conditions like active infections or recent major surgery.Check my eligibility
What is being tested?
The trial is testing different doses and schedules of Belantamab Mafodotin for relapsed/refractory multiple myeloma. This drug targets cancer cells by attaching to BCMA receptors on their surface and delivering a chemotherapy agent directly to them.See study design
What are the potential side effects?
Potential side effects include eye toxicity (vision problems), blood disorders, fatigue, liver issues, kidney dysfunction, and possible infusion-related reactions. The study aims to find dosing options that minimize these side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of multiple myeloma is confirmed by lab tests.
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My tests show I have measurable levels of M-protein or abnormal free light chains.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
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I am 18 years old or older.
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My myeloma has worsened after 3 types of treatments including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade 3/4 keratopathy-free rate
Secondary outcome measures
Incidence of adverse events (AEs)
Minimal residual disease (MRD) negativity rate
Overall response rate
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (low dose and high dose belantamab mafodotin)Experimental Treatment7 Interventions
Patients receive belantamab mafodotin IV on day 1. Cycle repeats at 3 weeks for the next cycle and then every 6 weeks for subsequent cycles in the absence of disease progression or unacceptable toxicity. All patients undergo a CT scan, a MRI scan, or a PET/CT scan during screening and patients with plasmacytoma (a MM tumor in bone or soft tissue) also undergo imaging scans on study. Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial.
Group II: Group I (low dose belantamab mafodotin)Active Control7 Interventions
Patients receive low dose belantamab mafodotin intravenously (IV) on day 1 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. All patients undergo a CT scan, a MRI scan, or a PET/CT scan during screening and patients with plasmacytoma (a MM tumor in bone or soft tissue) also undergo imaging scans on study. Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Belantamab Mafodotin
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,426 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,649 Patients Enrolled for Multiple Myeloma
Ricardo D ParrondoPrincipal InvestigatorMayo Clinic
Ricardo D. Parrondo, M.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis of multiple myeloma is confirmed by lab tests.I am currently being treated for an infection.I am HIV positive.My liver condition is stable.Your absolute neutrophil count is equal to or higher than 1.0 x 10^9 per liter.I have previously been treated with belantamab mafodotin.I have not had major surgery in the last 4 weeks.I have not received a live vaccine in the last 30 days.Your urine test shows low levels of albumin and creatinine, or the urine dipstick shows negative or trace amounts.My tests show I have measurable levels of M-protein or abnormal free light chains.Your alanine aminotransferase levels should be less than or equal to 2.5 times the upper limit of normal.I haven't taken any new myeloma treatments or investigational drugs in the last 14 days or less than 5 half-lives of the drug.I can care for myself and am up and about more than 50% of my waking hours.I have a risk for heart disease.I am currently experiencing bleeding from an internal organ or mucosa.I have not had plasmapheresis in the last 7 days.I have had a stem cell transplant more than 100 days ago or am not eligible for one.I have previously been treated with anti-BCMA therapies but not belantamab mafodotin.Your hemoglobin level is at least 8.0 grams per deciliter.Your bilirubin levels are not higher than 1.5 times the normal upper limit.Your liver function test should show a certain level of aspartate transaminase.Your kidney function, as measured by eGFR, is at least 30 mL/min/1.73 m^2.I am 18 years old or older.I have been diagnosed with Waldenstrom Macroglobulinemia.I am currently pregnant or breastfeeding.I have active plasma cell leukemia.I have symptoms caused by amyloid deposits.My myeloma has worsened after 3 types of treatments including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.Your blood platelet count is at least 50 billion per liter.I have active POEMS syndrome.I have only multiple myeloma or any other cancer I had has been stable for over 2 years.I have hepatitis B.You have tested positive for hepatitis C within the past 12 weeks.I have a mild eye surface condition, not severe.I have had a stem cell transplant from a donor.I don't have any major side effects from past treatments, except for hair loss or mild nerve issues.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (low dose and high dose belantamab mafodotin)
- Group 2: Group I (low dose belantamab mafodotin)
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.
Is this investigation open to participants at the current time?
"Contrary to what one might assume, clinicaltrials.gov has displayed that this medical experiment is not currently accepting participants at the moment. Initially posted on May 29th 2023, and last updated April 27th 2023, there are 818 other trials actively enrolling patients right now."
Answered by AI
Has the FDA approved Group II (low dose and high dose belantamab mafodotin) for clinical use?
"Our team at Power ranked the safety of Group II (low dose and high dose belantamab mafodotin) as a 2 due to there being some data on safety, but no efficacy data from Phase 2 trials."
Answered by AI
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