Study on Belantamab Mafodotin with Standard Treatment for Relapsed-Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT07227311
This clinical trial is testing a new treatment using belantamab mafodotin, combined with standard cancer medicines, for adults with multiple myeloma that has returned or isn't responding to current treatments. The study aims to see if this combination can effectively treat the cancer while reducing side effects, especially those affecting the eyes.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is for adults with multiple myeloma, a type of blood cancer, that has come back after previous treatment or isn't responding to current treatment. The main goal is to find out if belantamab mafodotin, given less often with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also evaluate how well the treatment works overall and its safety for participants.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of Multiple Myeloma.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Previously treated with 1 to 2 lines of therapy and have shown disease progression.
- Have measurable disease based on specific medical tests.
- If previously had a stem cell transplant, it must have been over 100 days ago, with no active infections.
- All previous treatment side effects must be mild or resolved, except for hair loss.
- Must have adequate organ function based on lab tests.
- Must follow contraceptive guidelines to prevent pregnancy during the study.
- For the BPd arm, must have had prior treatment with lenalidomide for at least 2 cycles.
Exclusion Criteria
- Have active plasma cell leukemia.
- Have symptomatic amyloidosis or certain other conditions.
- Have another invasive cancer unless stable for 2 years and not receiving active treatment.
- Have allergies to belantamab mafodotin or similar drugs.
- Have had plasmapheresis within 7 days before starting the study.
- Have had an allogeneic stem cell transplant.
- Have had major surgery within 4 weeks before starting treatment, except for bone surgery.
- Have active bleeding issues.
- Cannot tolerate antiviral medications.
- Have certain eye conditions, except mild ones.
- Have had recent systemic anti-myeloma therapy or monoclonal antibody treatment.
- Have active kidney issues, except for certain conditions related to multiple myeloma.
- Have had prior BCMA-targeted therapy.
- Cannot wear contact lenses during treatment, except as directed by an eye specialist.
- Have uncontrolled HIV, hepatitis B, or C infections.
- Have significant liver issues or cardiovascular risks.
- For the BPd arm, cannot have had prior treatment with pomalidomide or recent blood clots.
- For the BVd arm, cannot be intolerant or resistant to bortezomib or have severe nerve pain.
- For the BKd arm, cannot be intolerant or resistant to carfilzomib, have certain heart issues, or need fluid drainage procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 90720 | Los Alamitos | California |
| GSK Investigational Site | 90505 | Torrance | California |
| GSK Investigational Site | 90602 | Whittier | California |
| GSK Investigational Site | 33912 | Fort Myers | Florida |
| GSK Investigational Site | 31210 | Macon | Georgia |
| GSK Investigational Site | 20817 | Bethesda | Maryland |
| GSK Investigational Site | 65807 | Springfield | Missouri |
| GSK Investigational Site | 87401 | Farmington | New Mexico |
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