Trials / Not Yet Recruiting
Not Yet RecruitingNCT07224672
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
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)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Belantamab mafodotin will be administered |
| DRUG | Cyclophosphamide | Cyclophosphamide will be administered |
| DRUG | Bortezomib | Bortezomib will be administered |
| DRUG | Dexamethasone | Dexamethasone will be administered |
Timeline
- Start date
- 2026-03-20
- Primary completion
- 2032-12-13
- Completion
- 2032-12-13
- First posted
- 2025-11-05
- Last updated
- 2026-03-17
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07224672. Inclusion in this directory is not an endorsement.