Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT04484623
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Belantamab mafodotin — DRUGHumanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
- Pomalidomide — DRUGImmunomodulatory drug (IMiD) will be administered.
- Dexamethasone — DRUGSynthetic glucocorticoid with anti-tumor activity will be administered.
- Bortezomib — DRUGProteasome Inhibitor will be administered.
Study Details
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
Key Dates
- Start date
- Oct 1, 2020
- Status verified
- Mar 2025
- Primary completion
- Jan 29, 2024
- Completion
- Oct 25, 2029
Study Design
- Enrollment
- 302 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
- Active Comparator: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
Primary Outcome Measure
Progression-Free Survival (PFS) [ Time Frame: Up to approximately 174 weeks ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85712 | - |
| GSK Investigational Site | Fort Myers | Florida | 33901 | - |
| GSK Investigational Site | Boston | Massachusetts | 02215 | - |
| GSK Investigational Site | Kansas City | Missouri | 64132 | - |
| GSK Investigational Site | Nashville | Tennessee | 37203 | - |
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