Study on Belantamab Mafodotin Before and After Stem Cell Transplant for Multiple Myeloma
Sponsor: University of Pennsylvania
ClinicalTrials ID:NCT04680468
This clinical trial is testing the use of belantamab mafodotin, a drug targeting a specific protein in multiple myeloma, before and after stem cell transplant. The study aims to see if this approach is safe and effective when combined with standard maintenance therapy.
Patient Parameters
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Program Overview
This study is focused on using a drug called belantamab mafodotin, which targets a protein found in multiple myeloma cells, as part of the treatment process for patients undergoing a stem cell transplant. The drug will be given before and after the transplant, along with standard maintenance therapy using lenalidomide. Researchers hope to find out if this combination is safe, well-tolerated, and effective in treating multiple myeloma compared to past data.
Eligibility Criteria
Inclusion Criteria
- Started treatment for active multiple myeloma within the last 12 months.
- Have a performance status score of 0 to 2, indicating good overall health.
- Have received no more than two previous treatments for multiple myeloma, with no worsening of the disease.
- Show at least a partial response to initial treatment but not a complete response.
- Eligible to receive a specific dose of melphalan for the transplant.
- Eligible for lenalidomide maintenance therapy after the transplant.
- Have adequate bone marrow and organ function.
Exclusion Criteria
- Have not used any investigational drugs or anti-myeloma treatments within 14 days before starting the study drug.
- Have not received treatment with a monoclonal antibody within 28 days before starting the study drug.
- Not enrolled in any other interventional clinical trial.
- Do not have amyloidosis or POEMS syndrome.
- Not pregnant or breastfeeding.
- Do not have unstable liver or biliary disease.
- Do not have active bleeding issues.
- Do not have serious kidney conditions.
- Do not have significant heart risks.
- Do not have serious or unstable medical or psychiatric conditions.
- Do not have other active cancers unless treated and stable for at least 2 years.
- Do not have active infections requiring antibiotics.
- Have not had major surgery in the last 4 weeks.
- Do not have significant eye disease.
- Do not have allergies to belantamab mafodotin or related drugs.
- Do not have active hepatitis B or C infections.
- Do not have active HIV infection unless well-controlled with treatment.
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