Trials / Active Not Recruiting
Active Not RecruitingNCT07217184
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5- Sub-study 5 - Belantamab Mafodotin and Isatuximab in Combination
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Belantamab mafodotin will be administered. |
| DRUG | Isatuximab | Isatuximab will be administered. |
Timeline
- Start date
- 2021-07-29
- Primary completion
- 2025-04-17
- Completion
- 2027-03-11
- First posted
- 2025-10-15
- Last updated
- 2025-10-15
Locations
19 sites across 11 countries: United States, Australia, Brazil, Canada, France, Greece, Mexico, Norway, South Korea, Spain, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07217184. Inclusion in this directory is not an endorsement.