Trials / Active Not Recruiting
Active Not RecruitingNCT04484623
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered. |
| DRUG | Pomalidomide | Immunomodulatory drug (IMiD) will be administered. |
| DRUG | Dexamethasone | Synthetic glucocorticoid with anti-tumor activity will be administered. |
| DRUG | Bortezomib | Proteasome Inhibitor will be administered. |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2024-01-29
- Completion
- 2029-10-25
- First posted
- 2020-07-23
- Last updated
- 2025-03-18
- Results posted
- 2025-03-18
Locations
119 sites across 18 countries: United States, Australia, Brazil, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, New Zealand, Poland, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04484623. Inclusion in this directory is not an endorsement.