Study Comparing Belantamab Mafodotin with Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Newly Diagnosed Multiple Myeloma Patients Ineligible for Stem Cell Transplant
Sponsor: GlaxoSmithKline
Sponsor score: 60
ClinicalTrials ID:NCT06679101
This Phase 3 clinical trial is evaluating whether a combination of Belantamab Mafodotin, Lenalidomide, and Dexamethasone (BRd) can improve outcomes compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in patients with newly diagnosed multiple myeloma who cannot undergo stem cell transplantation.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to determine if the BRd treatment can help patients with newly diagnosed multiple myeloma live longer without their disease getting worse and achieve a state where minimal residual disease is not detectable, compared to the DRd treatment.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old or the legal age of consent.
- Able to provide informed consent and follow study requirements.
- Diagnosed with newly diagnosed multiple myeloma needing treatment.
- Must have measurable disease based on specific lab tests.
- Not eligible for high-dose chemotherapy with stem cell transplant due to age (70 or older), other health conditions, or personal choice.
- Good overall health with an ECOG performance status of 0 to 2.
- Adequate organ function based on lab tests.
- Male participants must agree to use contraception and avoid donating sperm during and after treatment.
- Female participants must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
Exclusion Criteria
- Have certain other blood disorders or types of cancer.
- Have had previous treatment for multiple myeloma.
- Have cancer affecting the brain or nervous system.
- Have had major surgery recently or not fully recovered from surgery.
- Have serious medical or psychiatric conditions that could interfere with the study.
- Have active liver or bile duct disease, except for certain stable conditions.
- Have other cancers unless stable for at least 2 years.
- Have significant heart problems or recent heart events.
- Have HIV unless well-controlled with treatment.
- Have hepatitis C unless successfully treated.
- Have hepatitis B unless specific criteria are met.
- Have current eye disease except for mild conditions.
- Cannot tolerate antiviral or blood clot prevention medications.
- Have allergies to study drugs or components.
- Have had plasmapheresis recently.
- Have received a live vaccine recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 36607 | Mobile | Alabama |
| GSK Investigational Site | 77339 | Kingwood | Texas |
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