Study Comparing Belantamab Mafodotin to Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT04162210
This clinical trial is testing the effectiveness and safety of a new drug, belantamab mafodotin, compared to a combination of pomalidomide and low-dose dexamethasone in patients with multiple myeloma that has returned or not responded to treatment.
Patient Parameters
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Program Overview
The study aims to compare the effects of belantamab mafodotin, given every three weeks, with a combination of pomalidomide and dexamethasone, given in 28-day cycles, in patients with relapsed or refractory multiple myeloma. Participants will continue treatment until their disease progresses, they experience unacceptable side effects, they choose to withdraw, or the study ends.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent.
- Aged 18 or older (19 in South Korea).
- Performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Confirmed diagnosis of multiple myeloma, having undergone or being ineligible for stem cell transplant.
- Received at least two prior treatments for multiple myeloma, including lenalidomide and a proteasome inhibitor, with disease progression or non-response.
- Measurable disease with specific protein levels in blood or urine.
- If previously had a stem cell transplant, it must have been over 100 days ago with no active infections.
- Adequate organ function based on specific blood test results.
- Agree to use effective contraception during and after the study, with specific requirements for men and women depending on the treatment arm.
- All previous treatment-related side effects must be mild or resolved, except for hair loss and mild nerve damage.
Exclusion Criteria
- Active amyloidosis, POEMS syndrome, or plasma cell leukemia.
- Recent treatment with anti-myeloma drugs or investigational drugs.
- Previous treatment with certain monoclonal antibodies or specific therapies.
- Recent plasmapheresis or major surgery.
- Active kidney issues requiring dialysis or affecting safety.
- Serious medical or psychiatric conditions that could interfere with the study.
- History of lung inflammation requiring steroids.
- Active bleeding or unstable liver disease.
- Other cancers unless stable for at least two years.
- Significant heart issues or uncontrolled high blood pressure.
- Allergies to study drugs.
- Pregnant or breastfeeding women.
- Active infections requiring treatment.
- HIV or hepatitis infections unless controlled with specific criteria.
- Unable to tolerate blood clot prevention medications.
- Current eye conditions affecting the cornea.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 85715 | Tucson | Arizona |
| GSK Investigational Site | 81008 | Pueblo | Colorado |
| GSK Investigational Site | 48202 | Detroit | Michigan |
| GSK Investigational Site | 68130 | Omaha | Nebraska |
| GSK Investigational Site | 12065 | Clifton Park | New York |
| GSK Investigational Site | 45236 | Cincinnati | Ohio |
| GSK Investigational Site | 97330 | Corvallis | Oregon |
| GSK Investigational Site | 97401 | Eugene | Oregon |
| GSK Investigational Site | 75702 | Tyler | Texas |
| GSK Investigational Site | 53226 | Milwaukee | Wisconsin |
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