Study on Belantamab Mafodotin and Feladilimab for Treating Relapsed or Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline
Sponsor score: 60
ClinicalTrials ID:NCT07217119
This clinical trial is testing the safety and best dose of a new combination treatment using belantamab mafodotin and feladilimab for patients with relapsed or refractory multiple myeloma (RRMM).
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main goal of this study is to find out if the combination of belantamab mafodotin and feladilimab is safe and well-tolerated in patients with relapsed or refractory multiple myeloma (RRMM). Researchers also aim to determine the best dose for future studies. This study is part of a larger research program.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of multiple myeloma.
- Must have received at least three previous treatments for multiple myeloma, including specific types of drugs.
- If you had a stem cell transplant, it must have been more than 100 days ago, and you should not have any active infections.
- Must be in good general health, with a performance status score of 0 or 1, unless bone issues from multiple myeloma are the only reason for a score of 2.
- Must have measurable disease, which means certain levels of proteins in the blood or urine.
- If you have tested positive for Hepatitis B, you can still participate if certain conditions are met.
- Can be taking low doses of steroids or using inhaled or eye-drop steroids.
Exclusion Criteria
- Have current eye problems, except for mild issues.
- Have heart-related health risks.
- Have allergies to the study drugs or similar medications.
- Have an active infection needing treatment.
- Have used other monoclonal antibodies or anti-myeloma treatments recently.
- Have had radiation therapy recently.
- Have had a donor stem cell transplant.
- Have had CAR-T cell therapy with chemotherapy recently.
- Have had major surgery recently.
- Have used experimental treatments recently.
- Have severe side effects from previous treatments.
- Have had a blood transfusion recently.
- Should not receive live vaccines recently or during the study.
- Have active kidney problems, except for protein in urine from multiple myeloma.
- Have HIV, unless certain conditions are met.
- Have autoimmune diseases needing treatment in the past two years.
- Have had heart inflammation recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 30322 | Atlanta | Georgia |
| GSK Investigational Site | 53792 | Madison | Wisconsin |
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