Study on Belantamab Mafodotin and Nirogacestat for Treating Relapsed or Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline
Sponsor score: 60
ClinicalTrials ID:NCT07084896
This clinical trial is testing the safety and appropriate dosage of a new combination treatment using belantamab mafodotin and nirogacestat for patients with relapsed or refractory multiple myeloma (RRMM).
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to find out if the combination of belantamab mafodotin and nirogacestat is safe and well-tolerated in patients with relapsed or refractory multiple myeloma (RRMM). Researchers also aim to determine the best dose to use in future studies. This study is part of a larger research project.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of multiple myeloma.
- 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 over 100 days ago, and you should not have any active infections.
- Have a performance status score of 0 or 1, or 2 if due to bone issues from multiple myeloma.
- Have measurable disease based on specific medical tests.
- If you have tested positive for Hepatitis B, certain conditions must be met to participate.
- Can be on low-dose steroids or certain other medications.
Exclusion Criteria
- Have current eye disease, except for mild conditions.
- Have heart-related health risks.
- Have allergies to drugs similar to belantamab mafodotin or its components.
- Have active infections needing treatment.
- Have used other monoclonal antibodies recently or had certain cancer treatments within the last few weeks.
- Have had a recent allogeneic transplant or CAR-T therapy.
- Have had major surgery recently, except for bone-stabilizing surgery.
- Have had investigational treatments recently.
- Have severe side effects from previous treatments that led to stopping those treatments.
- Have had a blood transfusion recently.
- Have received live vaccines recently or plan to during the study.
- Have active kidney conditions affecting safety.
- Have HIV unless specific conditions are met.
- Have uncontrolled digestive or skin diseases.
- Have conditions causing low levels of certain minerals that can't be corrected.
- Have used a gamma secretase inhibitor before.
- Are taking certain strong medications that affect how the body processes drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| 238995 | 30322 | Atlanta | Georgia |
| 240593 | 02215 | Boston | Massachusetts |
| 251164 | 49546 | Grand Rapids | Michigan |
| 239015 | 53792 | Madison | Wisconsin |
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