A Phase 2, Open-label, Randomized, Dose Optimization Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)
GlaxoSmithKline
Summary
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Participant is at least 18 years of age or the legal age of consent * Has histologically confirmed newly diagnosed primary AL amyloidosis according to the following criteria: * Presence of an amyloid-related systemic syndrome as per consensus guidelines. * Positive amyloid staining by Congo red stain with green birefringence on polarized light microscopy in any tissue AND at least 1 of the following tests to confirm amyloid type as AL Characteristic appearance by electron microscopy or confirmatory immunohistochemistry or AL amyloidosis typing by mass spectrometric…