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Belantamab Mafodotin for Multiple Myeloma
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.
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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- 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.
- Group 1: Group II (low dose and high dose belantamab mafodotin)
- Group 2: Group I (low dose belantamab mafodotin)
- 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
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."
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."
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