Trials / Active Not Recruiting
Active Not RecruitingNCT04246047
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 494 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate |
| DRUG | Daratumumab | Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody |
| DRUG | Bortezomib | Proteasome Inhibitor |
| DRUG | Dexamethasone | Synthetic glucocorticoid with anti-tumor activity |
Timeline
- Start date
- 2020-05-07
- Primary completion
- 2023-10-02
- Completion
- 2026-06-19
- First posted
- 2020-01-29
- Last updated
- 2024-10-24
- Results posted
- 2024-10-24
Locations
144 sites across 20 countries: United States, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04246047. Inclusion in this directory is not an endorsement.